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0 - 1 years
2 - 6 Lacs
Navi Mumbai
Work from Office
Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for? contract conversion Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation
Posted 1 month ago
8 - 13 years
12 - 18 Lacs
Bengaluru
Work from Office
Leading BPO in Bangalore Hiring for Transactional Quality Manager International Voice Process Must be a Manager Quality /Tenured Deputy Manager On papers in an International BPO in Voice process BFSI EXPERIENCE IS MANDATORY Over All Experience 8+ Years CTC UPTO 18LPA based on Last CTC & experience Interested candidates can mail their cv at simmi@hiresquad.in or call at 8467054123 Role & responsibilities Act as a primary POC between the QA teams, OPS & clients. • Recommended responsibilities include but are not limited to the following: • Lead, manage, motivate, and mentor a team of Quality Analysts • Drive consistency to ensure the strong quality performance and alignment across all programs • Deliver process as well as agent level insights to continuously improve and deliver outstanding customer experience across the program • Work alongside Ops and hiring team to provide on-boarding, coaching, remediation, training and development for QAs and QA Leads • Implement and drive the QA process and structure • Identify possible issues and trends and give actionable insights while communicating them to relevant stakeholders • Implement initiatives and projects to counteract any possible trends, drive business KPIs • Aggregate audit findings and analyses gaps in processes, identifying innovative ways to solve problems upstream, help improve customer experience and drive higher efficiency • Analyses quality and performance trends to provide recommendations for program improvement • Responsible for the delivery of vendor quality metrics at management reviews Key skills & knowledge: Excellent communication & interpersonal skills Excellent MS Office skills (presentation & excel) Should have good knowledge of FMEA identification and mitigation of vulnerabilities Excellent knowledge of Quality & Analytical tools Should be well versed with Qualitative concepts Should have worked on process improvement projects driving Customer Experience, Process Improvements & Profitability Interested candidates can mail their cv at simmi@hiresquad.in or call at 8467054123
Posted 2 months ago
2 - 7 years
5 - 7 Lacs
Bengaluru, Gurgaon
Work from Office
Quality Analyst//Sr Quality Evaluator Leading BPO in Bangalore & Gurgaon International Banking Voice Process Must be working as Quality Analyst for minimum 1 Year on papers Must have Experience in BFSI Must be Excellent in 7QC Tools CTC UPTO 7.5LPA based on Last CTC Cabs in Odd Hours Looking for Immediate Joiners only PLEASE NOTE- THIS IS NOT TESTING PROFILE Role and Key Responsibilities: • Conduct Quality audits on Email, Chat & Calls and share feedback with agents. • Conduct compliance and Quality checks and ensure timely reporting. • Drive continuous improvement - make recommendations and drive improvement. • Data analysis and creation of designated reports/ presentations. • Strengthen Quality management processes/ framework to improve quality delivery. • Ensure data management for all deliverables and be accessible without any delay. • Client Escalation Management. • Participate in internal & external calibrations to ensure consistent scoring & feedback delivery approach. Key skills & knowledge: • Good verbal and written communication skills. • Hands on experience in MS Excel, Power Point presentations and Reporting knowledge. Good in QC Tools • Flexible to work in Shifts 24/7 Environment. • Ability to work under pressure and in strict timelines. Interested Candidates can call at 8467054123 or mail their cv at simmi@hiresquad.in
Posted 2 months ago
12 - 16 years
10 - 15 Lacs
Chennai
Work from Office
Roles and Responsibilities Responsible for overall Quality System Review & Improvements Handling and control of Non-conforming products. Responsible for review & approval of key Quality System Procedures, Standard Operating Procedures & other Master Documents. GAP Analysis of the process and products. Identifying the scope of improvement based on trend analysis. Putting forward the suggestions for improvements to the Management. Participation in audits, compliance and Tracking of Audit Compliances/Status. Review & closeout of Change Controls, Deviation Complaints & CAPA. Participating in Impact assessment, investigation & approval of deviations. Review & Approval of change controls, Deviations, OOS, CAPA, Market Complaints, etc. Ensuring implementation of software based QMS in the Organization. Ensure Compliance of Software based QMS Systems. Responsible for clearance of rejected Raw & Packing Materials. Desired Candidate Profile Candidate should have good communication skills and Pharmaceutical OSD Experience required
Posted 2 months ago
12 - 18 years
8 - 10 Lacs
Neemrana
Work from Office
Role & responsibilities Automotive experience must. Preferably in plastics injection molding. Strong leadership quality. Lead a team of quality engineers & supervisors to train, guide, inspire and take decisions to enhance quality. 8 types of wastage reduction. High level of interpersonal skills. Never to give up attitude. Six sigma black belt. Ensure compliance of laid down standards and improvise upon them. Well versed with Best Practices, Lean Management, TQM, All Quality Tools, Statistical Techniques. Kaizen, Poka Yoke, CAPA, Training Cycle implementation. Define standards and make sure that standards are in place to meet customer requirements. 4M monitoring and improvising. Develop and implement procedures for quality control, and inspect products to ensure they meet quality standards. Systematic working through PDCA cycles. Continuing review of existing production process controls, standards and identify the scope of growth. Data analysis to identify areas for improvement. Customer Satisfaction with respect to Quality. In-depth skill in Microsoft PowerPoint
Posted 2 months ago
3 - 6 years
3 - 4 Lacs
Howrah
Work from Office
Evaluate raw material suppliers to ensure compliance with quality standards also see that only high-quality raw materials are used. Quality testing instruments, including spectrometers, hardness testers, & ultrasonic testers are properly maintained. Required Candidate profile Investigate product defects and implement corrective and preventive action plans (CAPA) to minimize recurrence. Handling of any quality complaints from customers, dispatch, and internal teams.
Posted 2 months ago
1 - 3 years
2 - 4 Lacs
Rajkot
Work from Office
1. Conduct regular inspections of raw materials and components to ensure they meet required specifications before production begins. 2. Perform in-process checks and final product testing to ensure the finished blood collection tubes meet established standards for quality, safety, and performance. 3. Verify product labeling, packaging, and batch documentation for compliance with regulatory guidelines. 4. Ensure adherence to international regulatory standards such as ISO 13485, FDA regulations, and CE Marking requirements for medical devices. 5. Monitor and ensure compliance Prepare and submit required quality assurance documentation for regulatory audits and inspections. 7. Monitor production processes to identify potential quality issues, non-conformances, or deviations from established standards. 8. Lead root cause analysis investigations for quality issues and implement corrective and preventive actions (CAPA). 9. Work closely with the production team to optimize processes and ensure high-quality production output. 10. Conduct internal audits to assess the effectiveness of the Quality Management System (QMS) and ensure all documentation is compliant. 11. Oversee the handling of customer complaints and non-conformance reports (NCRs), ensuring timely resolution and feedback. 12. Maintain accurate and detailed records of quality control tests, inspections, audits, and corrective actions. 13. Ensure all quality assurance documents are up-to-date, accessible, and compliant with company policy and regulatory requirements. 14. Prepare quality reports and summary data for management review. 15. Provide quality-related training to production staff, emphasizing the importance of quality control and compliance with regulations. 16. Manage communications with customers regarding quality issues, ensuring that customer requirements are met and feedback is effectively incorporated into product improvements. 17. Identify, investigate, and manage non-conformities within the production process, working with cross-functional teams to address the root causes.
Posted 2 months ago
10 - 15 years
10 - 16 Lacs
Pune
Work from Office
Role & responsibilities : Develop, implement, and maintain a comprehensive Quality Management System (QMS) tailored to defence projects. Ensure QMS adherence to relevant industry standards such as ISO 9001, AS9100, and MIL-IPC/ J-STD, JSS 55555: 2012, MIL- 461 E/F, MIL-810 G, ESD S20:20 ,MIL 883 standards. Development and review of procedures, QAP, ATP, QTP, FAT, CBD etc. Conducting Reviews and internal audits as per MIL standards Conducting special Process validation and process audits. Develop vendors and conduct supplier/vendor evaluation audits. Develop measure and monitor KPIs, Process capability and key characteristics with SPCs - Cp, Cpk and Control charts Implementation of 5S, and experience in CAPA, RCCA and FMEA Ensure compliance with all defence sector regulations, standards, and client requirements and Lead internal and external audits, including audits by defence clients, and coordinate the implementation of corrective actions. Lead the development of project-specific quality plans, including inspection and test plans, quality procedures, and work instructions Collaborate with project managers to integrate quality planning into overall project planning Ensure that all materials and components meet required quality standards before being incorporated into defense projects. Ensure rigorous testing and validation processes are in place to address quality risks. Maintain accurate and comprehensive documentation related to quality activities Preferred candidate profile : Good Understanding f AS9115, AS9102 and AS9103 and relevant Mil Standards Good understanding of industry and regulatory requirements for defence Industry. Good exposure to, IPC/ J-STD, JSS 55555: 2012, MIL- 461 E/F, MIL-810 G, ESD S20:20 standards. MIL 883 standards. Lead and mentor a team of quality assurance and control professionals. Provide training and development opportunities to enhance the skills and knowledge of the quality team. Serve as the primary point of contact for all quality-related matters with defence clients and regulatory bodies. Bachelors degree in Engineering, Quality Management, or a related field. Masters degree or MBA is a plus. Minimum of 10-15 years of experience in quality management, with at least 5 years in a senior leadership role within the defence sector. Proven track record of managing quality in complex, high-stakes defence projects. Certified Quality Engineer (CQE), Certified Quality Manager (CQM), or similar certification preferred. Six Sigma Black Belt or Lean certification is a plus. Willingness to travel as needed to project sites, supplier locations, and client meetings. Interaction with DGQA, CQAE(N), CEMILAC, DGAQA, DGNAI, MSQAA and RDSO/Railways agencies is desirable
Posted 2 months ago
5 - 8 years
3 - 7 Lacs
Pune
Work from Office
Job ID/Reference Code INFSYS-NAUKRI-210982 Work Experience 5-8 Job Title Medical Device - Mechanical Engineer Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams towards developing optimized high quality code deliverables, continual knowledge management and adherence to the organizational guidelines and processes. You would be a key contributor to building efficient programs/ systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you!If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Technical and Professional Requirements: Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology->CAD->CAD - Others Educational Requirements Master Of Engineering,Master Of Technology,Bachelor Of Engineering,Bachelor Of Technology Service Line Engineering Services * Location of posting is subject to business requirements
Posted 2 months ago
2 - 7 years
2 - 5 Lacs
Pune
Work from Office
Writing procedures and processes to support the QMS development Providing training and championing the Quality Management System Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met
Posted 2 months ago
6 - 8 years
6 - 8 Lacs
Udaipur
Work from Office
Day-to-day coordination with our customers for orders and ensuring targets to be achieved. Assistance in all the analytical work of Sales, Costing & related profits. Assistance in all the works related to Costing of new products to be pitched Required Candidate profile Monitoring sales targets on day to day basis and highlighting issues wherever required. New product developments with existing customers along with Business Development Team to increase Sales.
Posted 2 months ago
4 - 9 years
4 - 5 Lacs
Pune, Gurgaon, Mumbai (All Areas)
Work from Office
Responsible for preparation and use of SOPs in all departments as per the laid down procedures. Responsible for online and facility audits of QC and warehouse . Responsible for monitoring adherence to various laid down procedures in receipt, storage
Posted 2 months ago
8 - 12 years
5 - 7 Lacs
Zirakpur
Work from Office
Manage Team & Product inspection into different sites(Zirakpur/Noida /All CMS), Production Ispection Reports,Adherence Quality Standards & Specifications, UpdatePharmaceutical Regulations, Guidelines & Industry Trends. Share CV on jobs@asmohlab.com Required Candidate profile Review & approve batch record for Products ensure compliances with Specifications and GMP requirements, Change Control Process, Lead Investigations into Quality Issue, CAPA Plans
Posted 2 months ago
10 - 15 years
9 - 12 Lacs
Baddi
Work from Office
Role & responsibilities Preferred candidate profile Perks and benefits
Posted 2 months ago
12 - 15 years
10 - 12 Lacs
Baddi
Work from Office
Efficiently monitor all operations which affect the quality. Devise procedures for inspecting and reporting all the persisting quality issues. Assure the consistency and reliability of production with thorough checking procedures and final output. Supervise and guide inspectors, technicians, and all other staff. Report all malfunctions to production executives only to ensure immediate action. Appraise all the requirements of customers and ensuring they are quite satisfied. Facilitate proactive solutions by collecting and analyzing quality data. Keep permanent records of quality reports, statistical reviews, and relevant documentation. Review the current standards and policies. Communicate with external quality assurance officers during on-site inspections. Efficiently ensure that all the legal standards are met with great care. Provide assistance during the recruiting process. Efficiently create reports for tracking progress.Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications. Perks and benefits: Mention available facilities and benefits the company is offering with this job.
Posted 2 months ago
6 - 8 years
4 - 7 Lacs
Navi Mumbai, Thane, Mumbai (All Areas)
Work from Office
Role Overview Responsible for qualification & calibration activities for defined instruments and equipment as per schedule & procedures with QMS. Illustrative Responsibilities Ensure that qualification & calibration activities are planned and executed within time frame defined by the procedure and equipments are released on time as per the pre-defined schedule. Responsible for coordinating with lab supervisors / system owners for handling of any non-conformances or escalations Handling of QMS related activities like, Change control, CAPA and Deviation with its effectiveness check. Responsible for quality compliance activities for laboratory instruments qualification and calibration. Summarize, review, and report the analytical Instruments qualification and calibration for further approval. Ensure a disciplined work environment to provide expertise to subordinates colleagues in the proper performance of laboratory procedures. Ensure on time GDP in technical function with right first time (RFT) approach. Responsible for ensuring team compliance to EHS, Quality & Business policies Any other work given by management from time to time. Quality & Compliance Responsible for following GMP/GLP/ GDP/EHS policies by self as well as the team Required skills Technical expertise in Analytical instruments qualification, calibration, protocol preparation and QMS. Build cohesive team valuing team spirit Able to anticipate the implications and consequences of situations and take appropriate actions in the interest of Client as well as Cal Scientific without compromising quality. Clear thoughts and effective and crisp communication. Job requirement M.Sc – specializing in Chemistry/ M. Pharma with proven experience of min. 7-8 yrs. in Instrument qualification and calibration. In depth experience in Chromatography (HPLC, UPLC, GC), Spectroscopy (MS, FTIR, UV), Thermal techniques (DSC, TGA) and Particle size measurements. Expertise in analytical instruments qualification and calibration, protocol preparation, CAPA, Investigations, Deviations (QMS) Good Knowledge of ICH guidelines and different global regulatory authorities.
Posted 2 months ago
2 - 3 years
2 - 3 Lacs
Manesar
Work from Office
1.Knowledge of plastic injection molding & Quality background. 2. Basic knowledge of IATF & EMS Documents & core tools 3. knowledge of CAPA Preparation , 8D , process & product audit 4. Should be from mechanical & automobile background Required Candidate profile 1.Knowledge of IATF & EMS Documents. 2.Good communication skills (Proficient in English) 3.Educational Qualification :- B.tech Mech. 4.Minimum 2~6 years experience in plastic molding / Assembly. Perks and benefits Best in Industries.
Posted 2 months ago
3 - 5 years
5 - 10 Lacs
Rajkot
Work from Office
Alkem MedTech Pvt Ltd is a wholly owned subsidiary of Alkem Laboratories Ltd, which is the 5th largest listed Pharmaceutical company in terms of market share. As the first MedTech venture of Alkem Labs, Alkem MedTech is dedicated to advancing precision, high-risk, and implantable medical devices along with their accessories. MedTech is a strategic priority for Alkem Labs, representing a significant growth avenue. We are beginning our MedTech journey by focusing on Musculoskeletal solutions and have plans to expand into multiple segments, establishing a robust, multi-faceted MedTech company in the near future. Alkem MedTech will be manufacturing in India, aligning with the vision of the Government of India to boost domestic production and innovation in the medical technology sector. We are looking for passionate and innovative talents to join our pioneering team. If you are excited about shaping the future of medical technology and want to be part of a transformative journey, Alkem MedTech is the place for you. Why Join Us? Innovation-Driven Environment : Work on cutting-edge technologies in precision and implantable medical devices. Growth Opportunities : Be part of a strategic growth initiative for one of the leading pharmaceutical companies and be part of creating a legacy. Collaborative Culture : Engage with a team of dedicated professionals committed to making a difference in healthcare. Impactful Work : Contribute to life-changing medical solutions in the Musculoskeletal segment and beyond. Manufacturing in India : Support the vision of the Government of India by contributing to domestic production and innovation in the MedTech sector. Join us at Alkem MedTech and help shape the future of healthcare technology. Purpose of the role: The Microbiologist is responsible for ensuring the sterility of orthopedic knee and hip joint implants, monitoring microbiological processes, conducting microbiological testing, and ensuring compliance with relevant standards and regulations. This role involves conducting environmental monitoring, sterilization validation, and contamination control to ensure product safety and quality. Perform microbiological testing of raw materials, in-process samples, finished products, and environmental samples in accordance with GMP (Good Manufacturing Practices) and ISO standards. Conduct sterility testing, endotoxin testing, and bioburden testing of implants and related materials. Monitor and maintain environmental controls in cleanrooms, including air, surface, and personnel monitoring. Validate sterilization processes (e.g., Ethylene Oxide, Gamma Radiation) and perform routine sterilization cycle monitoring. Investigate microbial contamination events and implement corrective and preventive actions (CAPA). Maintain microbiological laboratory instruments, ensuring calibration, validation, and proper maintenance. Prepare detailed reports on microbiological findings, test results, and environmental monitoring data. Ensure compliance with regulatory requirements including FDA, ISO 13485, and EU MDR. Provide microbiological support during audits and inspections by regulatory bodies. Develop and review microbiological standard operating procedures (SOPs) and test protocols. Train and mentor junior staff on microbiological procedures and aseptic techniques.
Posted 2 months ago
4 - 8 years
5 - 9 Lacs
Kolkata
Work from Office
Trustegic is looking for QUALITY CONTROL MANAGER to join our dynamic team and embark on a rewarding career journey. Developing, implementing, and maintaining quality control procedures, policies, and systemsManaging and overseeing the quality control team and providing guidance, direction, and training to team members Developing and monitoring quality control metrics and key performance indicators (KPIs) to ensure compliance with quality standards and customer requirements Conducting quality control audits and inspections to identify non-compliance issues, defects, and areas for improvement Developing and implementing corrective and preventive actions to resolve quality issues and prevent their recurrence Collaborating with cross-functional teams, including engineering, manufacturing, and customer service, to identify and resolve quality issues and improve processes Maintaining and updating documentation related to quality control processes, procedures, and systems Conducting quality control training programs for employees to ensure that they are aware of quality control standards and procedures Participating in customer meetings and conducting customer surveys to assess customer satisfaction and identify areas for improvement Strong leadership and analytical skills, as well as excellent communication skills
Posted 2 months ago
3 - 8 years
4 - 5 Lacs
Bengaluru
Work from Office
Need a QMS expert ( QA Experience) with experience in Change Control, CAPA, and Investigation SOP preparation and review, with a minimum of 4–5 years of experience maximum 5 - 5.5LPA. Required Candidate profile Need a QMS expert ( QA Experience) with experience in Change Control, CAPA, and Investigation SOP preparation and review, with a minimum of 4–5 years of experience maximum 5 - 5.5LPA.
Posted 2 months ago
2 - 5 years
2 - 4 Lacs
Visakhapatnam
Work from Office
Roles and Responsibilities JD for QC officer 1. Monitor and maintain quality control processes and procedures to ensure that products or services meet established quality standards. 2. Quality Assurance: Implement quality assurance practices to prevent defects or errors and to maintain consistent product or service quality. 3. Quality Management System: Assist in the development, implementation, and management of a quality management system. 4. Documentation: Maintain and update quality documentation, including standard operating procedures, work instructions, and quality manuals. Other skills required : Required Skills Inspection and recording Monitor and maintain quality control processes and procedures to ensure that products or services meet established quality standards. Quality Management System Documentation Desired Candidate Profile B- tech (EEE/ECE/Instrumentation)/ Bio Medical Engg. Good Knowledge of Tools Methods and Concepts of Quality Control Perks and Benefits Insurance Bonus Leaves Performance appraisal Career Growth Job security
Posted 2 months ago
8 - 10 years
6 - 7 Lacs
Bengaluru
Work from Office
To ensure that process is carried out as per system and customer requirements. Handling customer complaints and monitor organization has met customer requirements. Responsible for yield at various stages of production processes. Authorized to stop the process in case of non conformity and work with production and process development for solutions. To ensure that identification and traceability are maintained as per requirements. Track issues, get corrective actions and ensure the closure. Raise internal NC report and ensure the closure and effectiveness. Actively participate on ECP meetings, APQP meetings and Customer complaint meetings and ensure it is effectively implemented in line. Organize Operational meetings and Quality review meetings (for yield improvements) and track actions for closure. To learn current updates and developments in the field. To perform continual improvement projects and give suggestions for improvements. Quality point of contact for any customer concerns. Recording customer complaints and acknowledge the customer with containment actions. Analysis with cross-functional team with the help of quality tools Plan corrective and preventive action against customer complaints together with the related departments. To effectively follow-up the action items related to customer complaints and ensure effective closure. To review and initiate for any process / engineering / document changes wherever necessary. Update 8D report and send to customer. To monitor and audit the effectiveness of the corrective and preventive actions. To review the RMA request from customers, Allocate RMA number and communicate to customers. To arrange / attend RMA meetings, analyze RMA rejections, plan corrective actions and to keep data, track and close the loop. To visit customers as and when required for warranty rejection analysis as well as customer complaints.
Posted 2 months ago
12 - 16 years
40 - 45 Lacs
Bengaluru
Work from Office
xternal Job Description Quality Culture: - Ensure awareness for quality focus to increase customer satisfaction, particularly in the development process - Plan, implement and live Quality culture within Product Line and organization level (Implement the defined processes, improve product quality, initiate process improvements, and drive continuous improvements (CI) in projects) - Ensuring compliance (of products) with legal and normative requirements (including tailoring of processes as appropriate) - Effectively review product risk management activities (including Risk Analysis, Risk Management Report) - Collaborate with onsite teams to keep project teams aligned with headquarters expectations - Drive best practices within the organization Quality Management: - Define quality strategy in Quality Management Plan - Drive process compliance in the complete lifecycle process of the medical device - starting with product definition till End of Support - Act as independent reviewer for design reviews acc to QSR 820.30 (e) with the responsibility of defining and documenting the overall result of the design review. - Work with internal delivery team and other functions in order to meet the specified Quality Goals of the project - Supporting and consulting of employees in implementing and realizing the processes as well as decision about tailoring of defined processes - both according to the needs of the business and in compliance with statutory requirements - Identify opportunities to improve productivity and efficiency with lower costs, reduce non-conformance costs - Initiate and moderate the root cause analysis and monitor effective and timely implementation of CAPA Reporting and Coordination: - Prepare and provide input to the periodic reports as needed by headquarter team Audits and Assessments: - Conduct / Participate in Internal Audit and External Audits using MDSAP methodology. - Coordinate and ensure timely closure of audit findings Qualification Requirements - Bachelors or Masters in Engineering / MCA having an excellent academic track record. - Proficient in managing Quality of complete Software Medical Device Development lifecycle in distributed international environment. - Experienced in latest trends of Software Product Development (e.g. Trunk Based Development, Continuous Delivery (DevOps) etc) - Advanced Knowledge of standards and regulations like ISO13485, ISO 14971 and 21CFR820 QSR (knows in detail and practical application in regards to the Quality Management System) - Advanced knowledge of quality tools for Metrics data analysis and decision making - Advanced computer skills (MS Office tools like Word, Access, Excel, PowerPoint and Outlook) - Highly energetic and Go-getter - Proven ability to independently plan and successfully execute multiple projects based on business priorities. - Display of a high level of critical thinking in bringing successful resolution to high-impact, complex and cross-functional problems is expected. - Advanced knowledge of organization's business practices and issues faced and contributions to problem resolution of those issues. - Excellent organizational and communication skills (e.g. Moderation, presentation to all levels). - Auditor experience in Medical Device area is preferred. - 12 to 16 years of successful experience in Quality Management and demonstration of Key Responsibilities and Knowledge as mentioned above. Advanced degree MAY be substituted for experience, where applicable.
Posted 2 months ago
5 - 10 years
8 - 13 Lacs
Vadodara
Work from Office
Expanding renewables Transforming conventional power Strengthening electrical grids Driving industrial decarbonization Securing the supply chain and necessary minerals Role and Responsibilities: Proficient and hands on experience in all kinds of precision measuring instruments and its calibrations. Able to read and understand the Engineering drawings Hands on experience in NDT techniques Knowledge of raw material specifications and review of material test certificates. Knowledge of ISO Documentation. Proficient in Quality Tools like NC Management, Root Cause Analysis, CAPA, FMEA, 8D, 5 Why Planning, organization, and coordination of inspections at supplier facilities. Preparation, execution, and follow-up of non-destructive tests on steam turbines and associated components Supplier qualification, development, and active participation in the quality improvement of suppliers and purchased parts. Avoiding quality problems by developing preventive measures for suppliers Methods for quality assurance and analyzing the causes of defects and initiating appropriate corrective measures together with suppliers & in-house. Initiating, monitoring and actively pursuing corrective and preventive actions for repair parts Proactive collaboration with internal stake holders. Knowledge on SAP material master for quality inspections & GRN clearances. Good Communication skills in English Read, Write and Speak Good command on MS office tools Ready to travel across the country for vendor inspections. Experience in turbo machineries desirable Education & experience: B.E Mechanical or equivalent degree Certified ASNT NDT Level II in UT, MPT, LPT and VT 5 to 10 years of relevant professional experience Profound knowledge in the application of quality methods, such as 5 Why, FMEA, 8D, RCA Very good collaboration and communication skills required. Confident handling of MS Office applications and SAP Team player, precise work, high level of initiative and flexibility Constructive collaboration across all functions Willingness to travel for site support
Posted 2 months ago
2 - 7 years
4 - 6 Lacs
Dahej
Work from Office
Interview for Female for QA Department for Chemical Company in Dahej on 4 & 5 April Qualification: BSC / MSC Chemistry Experience: 3 to 7 Years CTC: Up to 6 LPA Only Female Share with your Female Friends Free Jobs, No Placement Charges Required Candidate profile Send CV on sdpbharuch@gmail.com with Subject: QA Female Dahej Join WhatsApp Group: https://chat.whatsapp.com/LelLOsEoGgmIaK6EBrWZWN Follow Us: https://whatsapp.com/channel/0029VaDwTZoHgZWddec9BL0y
Posted 2 months ago
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