1002 Gmp Jobs - Page 40

Job Description Position: Manager: CAPA Effectiveness Job Title: Manager: CAPA Effectiveness Job Grade: G10 Function: Global Quality and Compliance Sub-function: Corporate Quality Audit Manager s Job Title: Lead - CAPA Effectiveness Skip Level Manager s Title: Function Head Title: Location: Tandalja (Baroda R&D) No. of Direct Reports (if any) Job Summary Areas of Responsibility To conduct the CAPA effectiveness review activities at manufacturing sites of Sun Pharma as per the review plan To perform CAPA effectiveness review for CAPAs provided to Regulatory Authorities. To perform review of implementation status of Global CAPA across Sun manufacturing sites. To inform CAPA effectiveness review outcome to Lead / HOD and prepare CAPA effectiveness review report within stipulated timeline. Participate in Regulatory Audit Review activities of manufacturing sites of Sun Pharma, need basis. Sound knowledge of current regulatory requirements/expectations Effective interpersonal, communication and organizational skill Participate and support project work as allocated by reporting authority Travel Estimate Job Scope Internal Interactions (within the organization) External Interactions (outside the organization) Geographical Scope Financial Accountability (cost/revenue with exclusive authority) Job Requirements Educational Qualification B. Pharma or M. Pharma Specific Certification Skills QA Background, Knowledge of QMS or Compliance, US FDA experience is require. OSD and Sterile experience is require - sterile will be preferable Experience 10 to 16 years of work experience. Experience in a pharmaceutical organization with good exposure of Quality and Manufacturing Operations. A strong knowledge of GMP s and regulatory audits, CAPA assessments in international regulatory environments. Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Microbiological Testing & Analysis: Perform microbiological testing of raw materials, processed chicken, water, air, and surface swabs as per standards. Identify and analyze microbial contamination, ensuring corrective actions are implemented. Maintain detailed records of microbiological reports and analysis. Food Safety & Hygiene Compliance: Monitor and enforce hygiene and sanitation practices across the slaughterhouse. Conduct routine checks to ensure compliance with FSSAI, HACCP, ISO, and GMP standards. Ensure proper functioning and calibration of laboratory equipment used for microbiological testing. Quality Control & Documentation: Maintain and update microbiological documentation as per regulatory and company policies. Assist in implementing and maintaining Food Safety Management Systems (FSMS) . Conduct internal audits to ensure compliance with microbiological quality standards. Training & Awareness: Train plant staff on microbiological hazards, hygiene practices, and preventive measures. Work closely with the production and quality teams to improve food safety culture at the plant. Qualifications & Experience: Education: M.Sc./B.Sc. in Microbiology, Food Technology, or a related field. Experience: 25 years of experience in microbiological testing, preferably in a poultry/meat processing plant or food industry. Skills: Strong knowledge of microbiological testing methods and food safety regulations. Familiarity with HACCP, ISO 22000, FSSAI, and GMP guidelines. Proficiency in lab equipment handling and result interpretation. Good communication and training skills.

Hydrogen(H2),COA, CSA, CTA, OACE Continuous Vacuum Distillation Packing Column of 1-Phenoxy Ethanol Batch Vacuum Distillation Packing Column of 1-Phenoxy Ethanol Quaternization reactions (Exothermic and Endothermic reactions) Blending Processes Required Candidate profile Comprehensive knowledge in DCS system (YOKOGAWA) with plant operation Experience in handling emergency situation including chemicals like Bromine, Chlorine, SO2, H2SO4 & HCl Hydrogenation reaction

Monitor production, perform chemical analysis, and ensure compliance.

Good Skill in QMS Compliance, Change control Review, SOP Review, SOP Preparation, Deviation Management

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for Qualification and validation, SOPs and Formats preparation, Training co-ordination and other Engineering GMP activities. Responsible for projects and other activities as assigned. Job Responsibilities Execute all engineering operation as per established ARPL standards and procedures. Reports to Assistant Manager - Engineering and Maintenance at ARPL for day-to-day engineering activities of allotted Job responsibilities. Ensure completion of Scheduled Qualification for the Equipment like Air Handling Units, LAF (Clean air stations), Pass box system, Dust Collectors, De-Dusting booth, Compressed Air System, Nitrogen plant, Water System, Access Control system, Etc., Ensure preparation of protocols and completion of Facility Qualification, IOQ, PQ for modified and newly created area as per the organization requirements. Ensure completion of test like Air velocity and Number of air changes, Class of Air- Non-viable Particle count, Airflow Direction/Pattern & HEPA Filter integrity for Air handling unit qualification. Receipt and review of Qualification Reports and Certificates from qualification service provider. Ensure completion of Scheduled Qualification for the Equipment like Air Handling Units, LAF (Clean air stations), Pass box system, Dust Collectors, De-Dusting booth, Compressed Air System, Nitrogen plant, Water System, Access Control system, Etc., Execute / supervise the engineering department online documentation all time with respect to Equipment Qualification / Re-Qualification / Risk Assessment / Training / Re-Evaluation / Planner / Logbooks. Preparation, updating, Review and archival of Qualification protocols, filter replacement schedules, QSR documents. Prepare Performance Re-qualification protocols and reports in line with the cGMP requirements. Ensuring and maintaining safe workplace at ARPL all time in coordination to EHS personnel. Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements. Execute with quality assurance department for preparation and implementation of engineering department SOPs / Formats / System manual and other engineering documents. Ensuring and maintaining engineering inventory management /upkeep of minimum stock availability for engineering spares. Execute / supervise with the help of contractors on daily basis for follow up and completion of Qualification and other engineering cGMP documentation activities and projects. Coordinating and Attending training sessions on cGMP, Regulatory, SOP trainings, SAP trainings, latest technical & industrial developments related to Engineering. Address and resolve escalated complaints & grievances from user department. Performs all work in accordance with all established regulatory compliance and safety requirements. Notification creation, confirmation and TECO of Preventive Maintenance & Corrective Maintenance work orders in SAP Module. Demonstrate Behaviours that exhibit our organizational values values: Collaboration, Courage, Perseverance and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance program, Global Quality policies and procedures, Safety and Environment policies and HR policies. All other duties as assigned. Job Requirements Education Minimum Diploma Engineering/Bachelors degree in Engineering Knowledge, Skills and Abilities Having Knowledge in Calibration, Thermal Mapping, Qualification and its related Documentation. Having knowledge in QMS documentation. Having knowledge in utilities systems and equipment s. Having knowledge in Preventive maintenance process. Having good interpersonal and communicational skills. Having knowledge of ISPE, ISO and WHO Guidelines for pharmaceutical equipment and area Qualification. Shall have exposure to any of the regulatory audits like USFDA, MHRA, HC, TGA. Etc., Experience Minimum 3 years of experience for bachelor s degree or 5 years of experience for diploma in engineering in pharmaceutical industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Responsible for producing quality products and maintaining quality systems in the plant. Ensuring Data Integrity. Preventive and Breakdown maintenance of all plant machinery & utility equipment. Daily monitoring of utility consumption. Calibration of utility instruments as per schedule. New project activities. Legal compliance as per legal register Review of Calibration and Preventive Maintenance Schedule. Operation of Utilities for the Production department. Coordination with HOD for project implementation. Plant Round and Breakdown Review. GMP audit compliance to all internal & external audits & inspections. Allocation of manpower. Procurements of Spares & Inventory monitoring. Monitoring of Power / Boiler Fuel / Water / Diesel Consumption. Monitoring of daily consumption and stock of briquettes. Area cleaning monitoring as per the schedule. Operation and maintenance of utility equipment i. e. , HVAC, Boiler, Purified Water Plant, Air Compressors, Nitrogen Plant, Electrical Panels (PCC, MCC), DG Sets etc. MIS preparation consisting of utility consumption. Review of training matrix. ODS consumption monitoring. Checking of pressure vessels/safety valves Utility consumption analysis. Housekeeping record monitoring. Boiler feed water, blow down water, cooling water analysis as per SOP & frequency. Review of departmental objectives. Boiler Inspection (Yearly) Electrical inspection & related legal compliance. UV cartridge filter, vent filter, resins & carbon replacement. Capex / Opex budget preparation Responsible for IMS activities of Engg. Dept. To ensure all lightning arresters are in healthy condition. To determine internal & external QEHS issues as well as the needs and expectations of the relevant interested parties and monitor the same. To ensure the work permit system during maintenance activity. To ensure QEHS continual improvement projects at the site and monitor. To ensure disposal of waste. Responsible for IMS activities of engineering. Review of repetitive breakdown analysis. Review of performance appraisal. Testing of pressure vessel testing, Lifting tools & Stackers. Departmental objective review. Spares budget preparation. Sanitation Supervisor for the Engineering Department. Authorized to Investigate workplace-related Incidents, Near misses and Accidents. Authorized for reporting Hazards, Incidents, accidents and near-miss reporting Authorized to prepare and review OH&S performance document. Authorized to conduct training of employees and workmen related to OHSMS. Implementation of operation excellence activities BE Mechanical/Electrical

Production Planning and scheduling (day to day basis) - Ensuring resources available (BMR, Raw Material Manpower etc.) Liaison with QC/QA/STORE/Eng. Dept. for solving of trouble shooting problem. - Implementation and monitoring of GMP Standard. - Introduction and scale up of technology transfer. (New Prod 1ct) Constantly monitoring and improvement of product process, efficiency, services etc. - Documentation work, Monthly Report, data preparation (Process trend analysis) and root cause analysis. - Ensure the availability of consumable items & Planning of RM require as per campaign basis. - Ensure the documents related to process I cleaning / House Keeping. Control on fresh as well as recovered solvents/ spent solvent. - Ensure the solid and process waste transfer to respective area and record maintaining. - Other activities entrusted from time to time. Review the prepared/ Revision of BMR and SOP. - Operation of electronic system i.e.ONE HR portal, Metis Track wise, Minitab, Out Look etc. - Ensure Preventive Maintenance of Plant Equipments in time frame. Ensure the training to subordinates. - Extended Facility of reactor Area of production Planning and scheduling (day to day basis)

Issuance, archival and retrieval of documents Issuance of Control copies to respective dept Destruction of the GMP documents once the retention term has passed and controlled copies of the obsolete GMP documents. Tracking of all QA documents. Maintaining of backup of QA softcopies. Maintaining SOP/s with proper indexing. Preparation and review of SOPs. Management of QA stationary (controlled copies and logbooks) Dispatch and line clearance activities. Review of BMR/BECR Involving in handling of deviations, change control and related CAPAs To ensure data integrity compliances while performing activities. Competencies: Quick learner with excellent communication skills Punctual with proven track record of dedication & reliability A team player who is equally capable of working alone Fluent in both written and spoken English Knowledge /Experience in peptides

Responsible for producing quality products and maintaining quality systems in the plant. Ensuring Data Integrity. Preventive and Breakdown maintenance of all plant machinery & utility equipment. Daily monitoring of utility consumption. Calibration of utility instruments as per schedule. New project activities. Legal compliance as per legal register Review of Calibration and Preventive Maintenance Schedule. Operation of Utilities for the Production department. Coordination with HOD for project implementation. Plant Round and Breakdown Review. GMP audit compliance to all internal & external audits & inspections. Allocation of manpower. Procurements of Spares & Inventory monitoring. Monitoring of Power / Boiler Fuel / Water / Diesel Consumption. Monitoring of daily consumption and stock of briquettes. Area cleaning monitoring as per the schedule. Operation and maintenance of utility equipment i.e., HVAC, Boiler, Purified Water Plant, Air Compressors, Nitrogen Plant, Electrical Panels (PCC, MCC), DG Sets etc. MIS preparation consisting of utility consumption. Review of training matrix. ODS consumption monitoring. Checking of pressure vessels/safety valves Utility consumption analysis. Housekeeping record monitoring. Boiler feed water, blow down water, cooling water analysis as per SOP & frequency. Review of departmental objectives. Boiler Inspection (Yearly) Electrical inspection & related legal compliance. UV cartridge filter, vent filter, resins & carbon replacement. Capex / Opex budget preparation Responsible for IMS activities of Engg. Dept. To ensure all lightning arresters are in healthy condition. To determine internal & external QEHS issues as well as the needs and expectations of the relevant interested parties and monitor the same. To ensure the work permit system during maintenance activity. To ensure QEHS continual improvement projects at the site and monitor. To ensure disposal of waste. Responsible for IMS activities of engineering. Review of repetitive breakdown analysis. Review of performance appraisal. Testing of pressure vessel testing, Lifting tools & Stackers. Departmental objective review. Spares budget preparation. Sanitation Supervisor for the Engineering Department. Authorized to Investigate workplace-related Incidents, Near misses and Accidents. Authorized for reporting Hazards, Incidents, accidents and near-miss reporting Authorized to prepare and review OH&S performance document. Authorized to conduct training of employees and workmen related to OHSMS. Implementation of operation excellence activities BE Mechanical/Electrical

Lifepoint Multispeciality Hospital is looking for Quality Executive to join our dynamic team and embark on a rewarding career journey Understand customer needs and requirements to develop effective quality control processes Devise and review specifications for products or processes Set requirements for raw material or intermediate products for suppliers and monitor their compliance Ensure adherence to health and safety guidelines as well as legal obligations Supervise inspectors, technicians and other staff and provide guidance and feedback Oversee all product development procedures to identify deviations from quality standards Inspect final output and compare properties to requirements Approve the right products or reject defectives Keep accurate documentation and perform statistical analysis Solicit feedback from customers to assess whether their requirements are met Submit detailed reports to appropriate executives Be on the lookout for opportunities for improvement and develop new efficient procedures

implementation of QMS, Quality operations , Management of Product Returns, Handling, Storage of medical products, NC/CAPA at DC,Execute the activities related to QMS elements like Document Control, Change Control, Escalations,

The Purchase Head will manage sourcing, vendor negotiations, and procurement of raw materials for the utensils industry. Strong knowledge of supply chain management and cost control is required.

The Quality Head will be responsible for implementing and monitoring quality control measures, conducting audits, and ensuring compliance with industry standards. Experience in the utensils industry is a must.

review and execution of SOP, Master BMR and BPR, Qualification document and Validation document.Responsible for review of Executed BMR/BPR.monitoring, verification and review of IPQA activities on shop floor of Injectable Department, as applicable Required Candidate profile Deviation, Market complaint& OOS related to shop floor. QA SOPs & IPQA , Calibration& Preventive maintenance Line clearance, IPQA Activity, BMR checking, BPR Verification, Sampling activity

The Microbiologist will conduct quality testing, ensure product safety, and maintain hygiene standards.

Job Overview: We are seeking an experienced Procurement Manager with 5-8 years of experience in the processed food industry to manage sourcing and purchasing of raw materials, ingredients, and packaging materials. The ideal candidate will ensure cost-effective procurement while maintaining high-quality standards and regulatory compliance. Key Responsibilities: Develop and implement procurement strategies for raw materials (grains, spices, oils, preservatives, etc.), packaging, and other food production essentials. Identify and onboard reliable suppliers , ensuring quality, pricing, and timely deliveries . Negotiate contracts and pricing with vendors to optimize costs. Monitor supplier performance, food safety compliance, and adherence to industry regulations (FSSAI, HACCP, ISO, etc.). Collaborate with R&D and production teams to ensure ingredient specifications match product development needs. Conduct market research to assess pricing trends and sourcing alternatives. Maintain accurate inventory levels to prevent shortages or excess stock. Required Skills & Qualifications: Bachelors/Masters degree in Food Technology, Supply Chain, Business Administration, or a related field . 5-8 years of experience in food procurement, vendor management, or sourcing. Knowledge of food safety regulations and compliance standards (FSSAI, HACCP, GMP, etc.) . Experience with ERP procurement systems and supply chain analytics. Strong negotiation and contract management skills. 2: Supply Chain, Manufacturing & Operations Manager Processed Food Industry Department: Manufacturing & Operations Location: CHENNAI Reports to: DIRECTOR Job Overview: We are looking for a Supply Chain & Operations Manager with 6-10 years of experience in the processed food industry to oversee production, packaging, and inventory management . The role involves optimizing supply chain efficiency, ensuring regulatory compliance, and managing end-to-end operations for food production. Key Responsibilities: Oversee food production planning, raw material procurement, and packaging operations . Implement lean manufacturing techniques to optimize production efficiency and reduce waste. Ensure compliance with FSSAI, HACCP, ISO, and other food safety regulations . Manage inventory control , demand planning, and warehouse coordination. Optimize packaging processes to enhance product shelf life and meet sustainability goals. Work closely with R&D and quality control teams to ensure product consistency and adherence to food safety guidelines. Improve cold storage and supply chain logistics to maintain product freshness. Collaborate with sales and marketing teams to align production with demand forecasts. Required Skills & Qualifications: Bachelors/Masters degree in Food Technology, Supply Chain Management, or Operations . 6-10 years of experience in supply chain, food manufacturing, and operations. Expertise in lean manufacturing, Six Sigma, or process improvement techniques . Experience with inventory management, demand planning, and ERP software . Strong understanding of packaging materials, food safety, and quality control . 3. Job Title: Logistics & Delivery Manager – Processed Food Industry Department: Logistics & Distribution Location: CHENNAI Reports to: DIRECTOR Job Overview: We are hiring a Logistics & Delivery Manager with 5-8 years of experience in the processed food industry to manage storage, distribution, and last-mile delivery . The role focuses on optimizing cold chain logistics, reducing transportation costs, and ensuring timely, safe food deliveries. Key Responsibilities: Oversee warehouse operations, storage conditions, and distribution networks . Ensure temperature-controlled storage & transportation for perishable food items. Develop efficient logistics strategies for nationwide and regional distribution. Optimize last-mile delivery networks , ensuring on-time and safe delivery. Manage fleet operations , including transportation scheduling and tracking. Implement logistics tracking systems (WMS, GPS, RFID, etc.) for real-time monitoring. Work with regulatory bodies to ensure compliance with FSSAI, food safety, and cold chain guidelines . Reduce logistics costs while maintaining high delivery standards. Required Skills & Qualifications: Bachelor’s/Master’s degree in Logistics, Supply Chain, or Business Administration . 5-8 years of experience in logistics, distribution, or supply chain for processed food. Proficiency in warehouse management systems (WMS) and cold chain logistics . Strong problem-solving and route optimization skills . Ability to manage multiple transportation channels and ensure regulatory compliance .

Responsible for day-to-day activities of Quality Control, prepare and maintain documentation as per cGMP norms. Working Experience on HPLC is must Coordinate with other depart for smooth running of plant Capable of handling external Audits Required Candidate profile Min Exp 2 to 10 years in Quality department of a reputed pharmaceutical Company Knowledge of working in GMP Co. MS Office (MS Word & MS Excel) / ERP software. and good time management skills Perks and benefits Performance linked incentive & annual bonus extra

Responsible for day-to-day activities of Quality assurance, prepare and maintain documentation, BMR, BPR, SOPs as per cGMP norms. Line clearance, IPQA Coordinate with other depart for smooth running of plant Capable of handling external Audits Required Candidate profile Min Exp 2 to 10 years in Quality department of a reputed pharmaceutical Company Knowledge of working in GMP Co. MS Office (MS Word & MS Excel) / ERP software. and good time management skills Perks and benefits Performance linked incentive & annual bonus extra

Dear Candidate , Hirint at Kundli for Production Chemist in Pharma Industry. Salary- 25k to 35k as per skills Experience - 3 to 6yrs Qualification - B.sc, B.pharma Interested candidate call/whatsapp on 8222829929

Dear Candidate , Hirint at Kundli for Production Chemist in Pharma Industry. Salary- 25k to 35k as per skills Experience - 3 to 6yrs Qualification - B.sc, B.pharma Interested candidate call/whatsapp on 8222829929

Role & responsibilities Responsible for the Maintenance of Utilities like AHU System. To review daily logbooks of HVAC System. Preparation of Protocol and report for Validation of HVAC. Preparation of SOP's for new equipment's. Preferred candidate profile Should have experience in HVAC system with knowledge of Operation and Maintenance of BMS System. Should have experience in Preventive maintenance of Air Handling Unit (AHU) and Refrigeration System.

Bachelor’s Degree in Packaging Engineering with minimum 5+ years relevant experience from Medical Device/ Pharma industry Good experience in Medical Device Packaging Engineering with understanding and knowledge of Packaging materials and testing. Understanding of regulations and standards applicable to Med Device industry. Good experience in EUMDR Should have a good understanding of Packaging standards and Compliance requirements (ASTM, ISTA, ISO 11607). Good experience in creating protocols and reports. Good experience in understanding and documenting Design Change requirements from Packaging perspective Good experience in working with Product Lifecycle Management system. Good experience in understanding 2D Drawings. A good understanding of documentation management systems and good manufacturing practices (GMPs) is required. Good experience in working with multiple stake holders and coordination. Good knowledge of statistical methodology. Experience of Evaluate, create, and document package/product test methods for new product development and existing design improvements. Experience in close working with suppliers and OEM contacts to establish partnerships to maximize quality, delivery, and lead times, and to incorporate their abilities, ideas, and material/product knowledge into new development. Good experience in strong team skills, including communication, teamwork, initiative, and managed execution of all project deliverables.

A Day in the Life At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world Careers that Change Lives About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here Together, we can confront the challenges that will change the face of healthcare. Join us for a career that change lives. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together. In this exciting role as senior supplier quality engineer , your primary focus responsibility will be managing suppliers for released product engineering and manufacturing transfers by ensuring suppliers qualification documents are in accordance with the company requirements . You will be a key member of the Medtronic quality engineering team and responsible for coordinating A Day in the Life As a senior supplier quality engineer you will be : Responsibilities may include the following and other duties may be assigned. Qualify suppliers according to company standards management of approved supplier list per purchasing control compliance. Initiate and drives SCAPA s/NCR s to suppliers not performing/or adhering to company standards. Manage supplier change requests . Assess supplier performance on periodic basis drive necessary action for continous improvement. Establish a process ensures that suppliers deliver quality parts, materials, and services. Lead PPAP execution with supplier and ensure robust supplier process qualification/validation through IQ, OQ PQ methodology. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Provide pre-market quality engineering support to new product development (NPD) working in partnership with the component engineering and post-market supplier quality teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products. Collaborates with component engineers to develop and deliver the product acceptance sampling strategy, approved supplier list coordination, supplier owned quality deployment, PFMEA,MSA, ,control plans and relevant quality tools and methodologies for new products and legacy product. Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic test methods. Conduct audits to qualify supplier s for intended use for the business. Required knowledge, experience skills : Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 8 to 12 years of quality systems experience. Experience in supplier management is added advantage. Strong communication skills, both oral and written. Ability to comprehend principles of engineering, physiology and medical device use. Previous customer-facing and/or project management experience is a plus. Comfortable working with international and multi-cultural department and groups in different time zones . Accurate and delivers quality work, with a sense of urgency. Ability to work well under pressure and maintain positive, enthusiastic attitude. Ability to work in a fast-paced environment .Eagerness to learn and expand responsibilities accountablity . Skills - Nice to have : Good interpersonal skills. Previous experience working with global team (Aerospace, Defense, Med device, automobile preferably). Previous customer-facing and/or project management experience is a plus. Ability to work effectively in a team environment and build strong working relationships. ASQ Quality certification - CQE, CSQP, CQA. Working knowledge of Agile MAP PLM system, Standard, Guidance, and Regulations. Hand on experience on Minitab tools to perform statistical analysis. Exposure in auditing to FDA Quality System Regulation ISO 13485. Lean Six Sigma Green Belt or Black Belt. Benefits Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Benefits Compensation About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

A Day in the Life Careers that Change Lives About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.Learn more about our business, mission, and our commitment to diversity here Together, we can confront the challenges that will change the face of healthcare. Join us for a career that change lives. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together. In this exciting role as senior supplier quality engineer , your primary focus responsibility will be managing suppliers for released product engineering and manufacturing transfers by ensuring suppliers qualification documents are in accordance with the company requirements . You will be a key member of the Medtronic quality engineering team and responsible for coordinating A Day in the Life As a senior supplier quality engineer you will be : Responsibilities may include the following and other duties may be assigned. Qualify suppliers according to company standards management of approved supplier list per purchasing control compliance. Initiate and drives SCAPA s/NCR s to suppliers not performing/or adhering to company standards. Manage supplier change requests . Assess supplier performance on periodic basis drive necessary action for continous improvement. Establish a process ensures that suppliers deliver quality parts, materials, and services. Lead PPAP execution with supplier and ensure robust supplier process qualification/validation through IQ, OQ PQ methodology. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Provide pre-market quality engineering support to new product development (NPD) working in partnership with the component engineering and post-market supplier quality teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products. Collaborates with component engineers to develop and deliver the product acceptance sampling strategy, approved supplier list coordination, supplier owned quality deployment, PFMEA,MSA, ,control plans and relevant quality tools and methodologies for new products and legacy product. Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic test methods. Conduct audits to qualify supplier s for intended use for the business. Required knowledge, experience skills : Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 8 to 12 years of quality systems experience. Experience in supplier management is added advantage. Strong communication skills, both oral and written. Ability to comprehend principles of engineering, physiology and medical device use. Previous customer-facing and/or project management experience is a plus. Comfortable working with international and multi-cultural department and groups in different time zones . Accurate and delivers quality work, with a sense of urgency. Ability to work well under pressure and maintain positive, enthusiastic attitude. Ability to work in a fast-paced environment .Eagerness to learn and expand responsibilities accountablity . Skills - Nice to have : Good interpersonal skills. Previous experience working with global team (Aerospace, Defence, Med device, automobile preferably). Previous customer-facing and/or project management experience is a plus. Ability to work effectively in a team environment and build strong working relationships. ASQ Quality certification - CQE, CSQP, CQA. Working knowledge of Agile MAP PLM system, Standard, Guidance, and Regulations. Hand on experience on Minitab tools to perform statistical analysis. Exposure in auditing to FDA Quality System Regulation ISO 13485. Lean Six Sigma Green Belt or Black Belt. Benefits Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Benefits Compensation About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here