427 Qms Implementation Jobs - Page 7

Looking for Candidates who will be responsible for : QMS : Lead, maintain, and continually improve the companys Quality Management System in line with IATF 16949 and ISO 9001 requirements. Plan, execute, and monitor internal system audits per audit program; ensure auditor competency and closure of non-conformities. Facilitate management review meetings with actionable insights and data-driven inputs from core business processes. Ensure robust document and record control system as per standard; manage changes and version control across the organization. Ensure readiness for third-party and customer audits; lead responses to NCs and drive certification maintenance and renewals. Define and track KPIs for core and support processes; drive gap analysis and improvements. Oversee application of APQP, PPAP, FMEA, MSA, and SPC in relevant functions; support teams in correct and effective usage. Drive structured change control process for product, process, and system-level changes. Ensure deployment and compliance of Customer-Specific Requirements (CSR) within the QMS. Establish and monitor risk analysis and contingency planning for business continuity. Develop and deliver QMS training; build awareness across functions on quality standards and updates. Drive, Train & Facilitate QC & production for QC circle teams to resolve perennial issues. Localization : Responsible for establishing Quality of parts developed as per management initiatives. Support supplier for understanding current supplier product quality and guide in establishing a similar or supplier quality products. Support in completion of testing and validations of parts as per all applicable engineering standards and facilitate for customer approval as per the requirements stated by customer. Qualifications: Mandatory: B.E./ B.Tech Mechanical Desired: IATF / VDA certification Functional/Technical Competencies Required: IATF 16949, VDA 6.x, APQP, PPAP, FMEA, MSA, SPC, Control plan, VA/VE, Benchmarking, Customer management, Problem solving techniques, 8D approach, MS Office. Behavioural Competencies Required: Stake holder management, Communication, Leadership, Agile mindset, People management, Customer management, Supplier management, Self initiative & Proactive, Process driven approach. Key result areas / job outcomes: Drive and achieve QMS certifications by effective implementation of QMS Completion of internal system audit plan No of QCC projects completed Customer specific QMS implementation & rating / ranking as per customer systems % of parts localised as per management target Interested Candidates can send their CV on alka.p@peoplesource.in. Immediate joiners will be preferred. Alka Pathak Tiwari Senior Recruitment Consultant Email: alka.p@peoplesource.in

Role & responsibilities Maintain and implement QMS and EMS systems within the organization. Maintain quality and environmental Standards as per ISO-9000 (QMS) and ISO 14000 (EMS). Prepare all documents of Audit & provide control copy to each department and where ever applicable. Prepare Audit NC & take corrective & preventive action. Responsible for all Management Representative (MR) activity. Coordinate / collect data from each department and conduct MRM Meeting. Conduct internal Audit and External audit. Responsible for MPI/DP inspection, and coordinated with production team and ensure the results are delivered without delay. Responsible for all RT casting and complete follow up with RT inspection. Evaluation of RT film and interpret the test result and defect marking. Handling customer complaints / NCR and find out root cause / corrective action, and communicate to customer for closing. Conduct regular customer complaint meetings and monitor improvements. Identify key technical issues & report to HOD. Support to develop critical grades as per customer requirement (as per QAP). Support to identify supplier for Calibration of all Measuring equipment. Coordinate with production team, and work for despatch planning. Follow with special process, such as HT and welding. Give approval for carryout HT cycle and welding parameters. Develop welder qualification, and maintain welder continuity reports. Develop for WPS for new grade / existing up-gradation to customer requirements. Involve for New Product development activities. To Give training related to Audit and ISO Standard. Coordinating training programme for associates and team members. Maintain Discipline and safe working conditions. Preferred candidate profile Candidate having experience in foundry & casting with steel & Stainless steel Perks and benefits No bar for right candidate.

Develop, implement & maintain a robust Quality Management System (QMS) in compliance with applicable regulations (GLP, GCP, GXP, ICH guidelines) Create, review, and manage SOPs, work instructions, protocols, reports & documentation across departments Required Candidate profile 4+ years of experience in QA/QC within the pharmaceutical, biotech or drug discovery industry. Quality control certifications are preferred In depth understanding of QA/QC procedures & legal standards

1.Responsible for all floor QC,QA,QMS at plant 2, Team management, systems, work instructions and SOP adherence 3.ISO FSC, Sedex, 5S Audits and compliance 4 Ensure calibration of Lab Instruments as per NABL 5. CAPA,- RCA, report & corrective steps

Role & responsibilities Review and approve Finished Goods and corresponding Certificates of Analysis (COA). Maintain detailed records of received samples in an organized manner. Ensure proper allocation and storage of approved COAS in the shared drive. Verify and confirm drug product permissions as per regulatory requirements. Oversee the finalization of packing materials in coordination with relevant departments. Conduct audits of new vendors, ensuring compliance with quality standards. Ensure proper implementation of Corrective and Preventive Actions (CAPA) for any deviations or complaints. Visit manufacturing sites to address and investigate market complaints effectively. Coordinate with manufacturing partners for handling market and sample-related complaints. Perform joint analysis of complaint samples in collaboration with manufacturers to identify root causes. Maintain strict adherence to Good Documentation Practices (GDP). Possess sound knowledge of Schedule M, USFDA, MHRA and ensure compliance in relevant activities. Sound knowledge of IPQA (In-Process Quality Assurance) activities across different dosage forms (e.g., tablets, capsules, syrups, ointments, etc.) Sound knowledge of different types of SOPS (Standard Operating Procedures), including preparation, review, implementation, and compliance monitoring. Basic understanding of QMS (Quality Management System), including its elements and relevance in pharmaceutical operations.

Role & responsibilities Review and approve Finished Goods and corresponding Certificates of Analysis (COA). Maintain detailed records of received samples in an organized manner. Ensure proper allocation and storage of approved COAS in the shared drive. Verify and confirm drug product permissions as per regulatory requirements. Oversee the finalization of packing materials in coordination with relevant departments. Conduct audits of new vendors, ensuring compliance with quality standards. Ensure proper implementation of Corrective and Preventive Actions (CAPA) for any deviations or complaints. Visit manufacturing sites to address and investigate market complaints effectively. Coordinate with manufacturing partners for handling market and sample-related complaints. Perform joint analysis of complaint samples in collaboration with manufacturers to identify root causes. Maintain strict adherence to Good Documentation Practices (GDP). Possess sound knowledge of Schedule M, USFDA, MHRA and ensure compliance in relevant activities. Sound knowledge of IPQA (In-Process Quality Assurance) activities across different dosage forms (e.g., tablets, capsules, syrups, ointments, etc.) Sound knowledge of different types of SOPS (Standard Operating Procedures), including preparation, review, implementation, and compliance monitoring. Basic understanding of QMS (Quality Management System), including its elements and relevance in pharmaceutical operations.

Ensure ISO documentation compliance, read mechanical drawings, use measuring tools, understand basic GD&T, and report quality issues accurately. Good observation, reporting, and basic computer skills required. Apply: hr@cogmac.com Provident fund

DCM SHRIRAM RAYONS,KOTA JOB DESCRIPTION : MANAGERIAL POSITION, (Sr. Manager/ AGM) (QUALITY ASSURANCE) Location: Kota, Rajasthan Qualification: B.sc/M.Sc (chemistry), B.Tech Chemical/Textile/Rubber Technology Preferred Age: 40+ Years Experience: 20+ Years Location: Kota, Rajasthan Job Description: • Functioning of QCD and Chemical Laboratory – Updated Calibration status & adherence to scheduled testing, maintaining laboratory conditions and material clearance/ disposal decisions. • Process Control – SQC/SPC from Auxiliary to Dipping • Functioning of Management functions as per ISO – 9001, 14001 & 45001 in the unit. • Handling Customer Related matters – Conformance to committed actions, Root Cause Analysis/ Corrective actions. • Preparation for customer audits, external audits. • Preparation for IATF 16949 for Dipping plant • Coordination with Purchase/Textile for new vendor development activities. • Product/ New product development related activities. • Assessment of colleagues & deciding training needs. • Supplier Audits, CDP, Ecovadis, DINCERTO certification, MIS reports e.g., Division Reports, Monthly QCD Report • Leave management

Role & Responsibilities: Conduct third-party audits at client sites. Perform desk reviews of Quality Management System (QMS) documentation, including Batch Manufacturing Records (BMRs), Validation and Qualification protocols, and Standard Operating Procedures (SOPs). Provide comprehensive solutions for identified gaps or deficiencies during the review process. Ensure compliance with regulatory requirements and client standards. Preferred Candidate Profile: Expertise in handling Quality Management Systems. Skilled in reviewing Risk Assessments and investigation reports. Experience in analyzing and reviewing analytical data. Proficient in conducting third-party audits and preparing compliance reports. Competent in managing Corrective Action & Preventive Action (CAPA) processes. Well-versed in Process Validation, Cleaning Validation, and Analytical Method Validation. Excellent technical writing skills for documentation and reporting. Knowledgeable about the latest regulatory guidelines and standards. Willingness to travel across India for client visits. Flexible to work additional hours as needed. Proficient in Microsoft Office tools.

As a Hardware Engineer with over 10 years of experience, based in Udaipur, you will be responsible for designing, developing, and testing ATM hardware. Your role will involve working on mechanical designs to ensure compliance with industry and customer standards. Collaboration with software teams for system integration will be a key aspect of your work. An essential part of your responsibilities will include implementing and maintaining Quality Management Systems (QMS). This will involve conducting audits, defining quality procedures, and setting standards to ensure the highest level of quality in all hardware products. Proficiency in speaking and reading Japanese is a must due to the bilingual nature of the role. In this position, you will be expected to ensure adherence to both "Make in India" and global standards. You will play a crucial role in coordinating with certification bodies for product approvals, demonstrating your ability to work in compliance with various regulatory requirements. Vendor management will also be a significant part of your role. This will involve selecting vendors, handling procurement processes, and evaluating vendor performance based on criteria such as quality, cost, and delivery. Your expertise will be pivotal in maintaining strong relationships with vendors to ensure successful project outcomes. As a leader in hardware projects, you will be responsible for managing projects from concept to production. This will involve overseeing cross-functional teams, managing timelines, budgets, and utilizing available resources efficiently. Your technical expertise will be crucial in providing support to production teams to ensure smooth operations and high-quality output.,

Trackwise Consultant Experience: 5 to 8 Years Location:- Bangalore/Pune/hyderabad Notice period : Immediate to 15days Job Description Knowledge of Trackwise is a must Should have indepth knowledge of handling Quality management in TrackWise Should have a strong understanding of Trackwise Business processes such as Change Management System IncidentDeviation Investigation CAPA implementation etc Should have a deep understanding of the individual workflowsapprovals in each Trackwise Module Experienced in generating various types of queries in TrackWise requirements Well versed knowledge of Quality Risk assessment through TrackWise Application Should have managed QMS implementation projects including configuration migrations data migration multisite rollouts data archival etc Should have adequate knowledge in performing gap assessments from an end user perspective Need to ensure quality assurance procedures are followed and in accordance with Customers methodology and standards Minimum 5 years of experience in a Pharmaceutical Life Sciences setting is preferred Experience with industry standard and best practices regarding quality quality assurance and quality control principles and techniques eg 21 CFR Part 11 GAMP 5 Versed in health authority regulations such as FDA 21 CFR MHRA Annex 11 Subject Matter Expert in GxP GDP GLP GMP and Data Integrity Mandatory Skills : Architecture Principle Design, Software Engineering and Design Architecture, Trackwise

JOB DESCRIPTION SUMMARY: Owns Quality of value stream, compliance, internal audits, zero defect initiative, customer issue resolution (problem solving), customer satisfaction (NPS), and CoQ governance. Manages local QMS (quality management system) to ensure the continuous production of products consistent with established standards. Coaches, supports, instructs, and ensures the commitment of local management to operate at a high level of capabilities effectively. Follows company safety policies and procedures. ESSENTIAL DUTIES: Demonstrate leadership in communicating business goals, programs, and processes for various business functions. Utilize your experience or expertise to solve problems, develop and execute objectives for yourself and others. Support regulatory compliance and optimization of quality systems procedures relating to product complaint handling, adverse event reporting, and product field actions through the development, maintenance, and improvement of documented processes. Develop and implement quality metrics to drive manufacturing improvements and business results. Facilitate shop floor process improvement projects to reduce defect occurrence. Contact customers and liaise with SQE when necessary to confer on specific quality issues Identify, drive, mentor, and implement projects improving production quality. Work with the Technical Improvement and Operations team to drive process changes Responsible for the Quality of all in-house manufactured products Drive Lean effort within manufacturing, focusing on Quality MINIMUM REQUIREMENTS Drive Change. Strong organizational, analytic, and problem-solving skills. Ability to work in cross-functional teams in a matrix environment with all levels of personnel Strong working knowledge of Manufacturing and Quality operations. Demonstrated oral and written communication skills Strong interpersonal and leadership skills Ability to plan, prioritize, and manage multiple priorities under tight deadlines Ability to coach, manage, change and facilitate team performance Education & Knowledge: Degree from an accredited university preferred. Bachelor's degree in Mechanical engineering, Quality or a related field. ASQ certification in quality management is preferred. Knowledge and applications experience with ISO 9001 (International Standard Organization), API Standards and Quality Management Systems. Working knowledge and training in the ISO-9000 Series international standards, or equivalent. Basic knowledge of audit and audit Reporting requirements. Knowledge of the process approach, including audit methodology, questioning techniques, roles, and responsibility to collect and analyse evidence. Familiarity with standard concepts, practices, and procedures within oil & gas manufacturing and services is preferred. Sound understanding of business linkages and the ramifications that decisions can have. Work Experience: Typically, at least five years of progressively more responsible experience in a manufacturing environment. Experience in a similar industry (Oil & Gas) is desired.

Post- Quality Documentation Specialist Location - Pune Chakan Contact - 9356395439 Email - punejob2025@gmail.com Experience - 05-10 yrs Skills Certification in ISO 9001:2015 Internal Auditor or Lead Auditor. Prior experience in the renewable energy or heavy fabrication sector. Knowledge of ISO 45001 and ISO 14001 standards. Strong knowledge of APQP, PPAP, FMEA, Control Plans, and Process Flow Diagrams. Experience with ISO 9001 audits and OSHA safety documentation standards. JD Quality Documentation Specialist to manage and improve our documentation systems in line with industry standards. The ideal candidate should possess hands-on experience with PPAP, APQP, ISO audits, and OSHA documentation, and be well-versed in Quality Management Systems within a manufacturing environment. Prepare, review, and maintain quality documentation including SOPs, Work Instructions, Control Plans, and Checklists. Manage all documentation related to APQP and PPAP processes for new and existing products. Ensure document compliance with ISO 9001, ISO 45001 , and customer-specific standards. Support internal, customer, and third-party ISO audits by preparing audit trails and ensuring proper document control. Maintain and update safety-related documentation in line with OSHA requirements and company EHS policies. Coordinate with cross-functional teams (Engineering, Production, EHS) to keep documentation aligned with current practices. Maintain effective document control processes using electronic systems (e.g., SharePoint or QMS platforms). Support training sessions for staff on new or revised documentation. Proactively identify and implement improvements to document processes.

We are seeking a knowledgeable and detail-oriented IRIS Audit Specialist to oversee and execute Quality Management System (QMS) audits in alignment with the International Railway Industry Standard (IRIS) , specifically ISO 9001 and ISO 22163 . The ideal candidate will bring a solid understanding of quality principles, railway industry standards, and auditing techniques. They will play a key role in planning, conducting, and reporting IRIS audits and guiding continuous improvement initiatives within the organization. Key Responsibilities: Plan, schedule, and conduct internal IRIS audits in accordance with ISO 22163 and ISO 9001 standards. Use the IRIS Audit Tool and Portal for accurate audit execution and documentation. Evaluate the effectiveness of Quality Management Systems using a process-based, risk-driven approach. Review and assess compliance with railway-specific requirements, including operational and regulatory standards. Identify, document, and classify non-conformities; support the implementation of corrective and preventive actions (CAPA). Deliver clear and concise audit findings and reports to relevant stakeholders. Monitor follow-up actions to ensure timely closure of audit issues and drive continuous improvement. Liaise with external auditors and support third-party IRIS certification or surveillance audits. Train and guide internal teams on IRIS requirements, audit readiness, and QMS best practices. Analyze IRIS performance levels and contribute to achieving higher ratings (e.g., Silver, Gold). Keep updated with industry changes, IRIS portal updates, and evolving regulatory requirements. Required Qualifications & Skills: Bachelor's degree in Engineering, Quality, Industrial Management, or related field. Minimum [X] years of experience in Quality Management or IRIS auditing within the railway or industrial manufacturing sector. Strong knowledge of ISO 9001 and ISO 22163 (IRIS Standard). Proven experience in conducting IRIS audits , including audit planning, execution, and reporting. Proficiency with audit techniques such as interviewing, observation, and document review. Familiarity with the IRIS Audit Tool and IRIS Portal usage. Experience in non-conformance management and CAPA processes . Strong communication, interpersonal, and presentation skills. Ability to work independently and collaboratively across cross-functional teams. Detail-oriented mindset with a commitment to continuous improvement . Preferred Certifications: Certified ISO 9001 Lead Auditor or equivalent. IRIS Auditor Certification (if applicable or preferred). Six Sigma or Lean certification (optional but beneficial).

Post - QMS -Manager Qualification : BE Electrical or Electronics Location Pune chakan Contact - 9356395439 Email - jobpune12@gmail.com Experience : 5 + yrs experience in control Panel manufacturing Salary : No bar for the right candidate. QMS Development and Implementation: Establishing and maintaining the QMS according to relevant standards like ISO 9001, AS9100, or IEC 61439-1 & 2, as applicable. Compliance: Ensuring adherence to all relevant standards, regulations, and customer requirements. Documentation: Managing and controlling QMS documentation, including procedures, work instructions, and control plans. Audits: Conducting internal audits, coordinating external audits, and managing responses to audit findings. Non-Conformance Management: Identifying, investigating, and resolving non-conformities, implementing corrective and preventative actions (CAPA). Customer Complaints: Managing customer complaints, conducting root cause analysis, and implementing preventive measures.

Job Responsibilities Operations Build successful relationships with Life Sciences (LS) client stakeholders to promote confidence in quality and compliance, as well as forward planning. Provide management and leadership direction for the development and implementation of quality and compliance programs. Collaborate with other Life Sciences accounts to proactively accumulate, share and reapply all learnings, successes as well as best practices. Collaborate with Global Life Sciences Quality Vertical for development, revision and implementation of QMS and quality documents. Responsible for ensuring Lide Sciences facilities teams adhere to the required training and ensuring in compliance to clients QMS and quality training requirements. Responsible for ensuring that the work conducted by the Facilities team, and its subcontractors is in full compliance with contractual requirements, clients SOPs, GxP, FDA and other regulations. Able to perform/support internal JLL compliance audits and prepare SOPs, and training materials for use by the Life Sciences facilities team in the performance of their work. Guide Life Sciences facilities team in closing recommendations from clients audit. Expected to interface with the clients quality personnel to ensure that all of the clients SOPs are followed, work performed by the LS facilities team is properly documented for traceability in the framework of GDP. Sustain quality assurance support and develop a Quality Engineering Maintenance program for a controlled-environment manufacturing and laboratory facility as it relates to the facilities maintenance of this plant. Conduct investigations and drive accountability for all quality events. Lead programs to create value for client to ensure program deliveries meet or exceed expectations. Facilitate quality-relevance investigation via structured Root Cause Analysis. As part of career development, lead Life Sciences accounts as an IFM leader.Reporting Manage and report on critical & key performance measurements. Develop and submit periodic site status reports related to the Quality Program. People Management Effectively lead and guide a Life Sciences Quality team by clearly communicating expectations, accountabilities and providing performance feedback for continuous improvement. Ensure Life Sciences Operations team members complete relevant quality and compliance training. Coach new Life Sciences team members on quality and compliance for their adaptation into specific Life Sciences accounts. Mentor, develop and train peer and direct report team members. Provides direction/information to vendors, facilities staff and service providers as required to ensure that quality assurance expectations are communicated and followed.Others Any other quality-relevant duties and tasks assigned. Knowledge, Skills & Abilities. MINIMUM REQUIRED / PREFERRED - Education/training Bachelor degree preferred Degree in science, technical or relevant discipline Sound fundamental knowledge in process utilities. 6+ Years of relevant experience preferred with minimum 4+ years in Quality and Compliance discipline in GxP manufacturing or laboratory environment. Six-Sigma and Root Cause Analysis training is essential. Skills and knowledge Background in technical documentation Work independently and within a team. Strong mindset of compliance and client-focus. Communicate effectively with technical, quality assurance and other personnel. Proficient in Word, Excel and other Microsoft Office Suite programs Ability to investigate, recognize and diagnose trends and patterns. Solid understanding of cGMPs as they relate to the performance of maintenance and repairs to facilities, utilities and equipment utilized for the manufacturing plants and laboratories for drug products. Experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity. Support investigations and corrective action plans for appropriate discrepancies. Investigation of compliance issues as required, collaborating with relevant Compliance Partner(s) Understanding of FDA regulations including 210 CFR part 210 and 211. Strong commitment to quality assurance, and a willingness to help develop a quality first culture on the site. Knowledge of Quality Engineering techniques, CMMS systems, and Quality Management Systems English communication is essential Other abilities Good oral and written communication skills including the ability to communicate to all levels of management and willing to interface with a diverse customer base including technical and non-technical personnel.Physical work requirements and work conditions Familiar with process utilities and GxP environment.

Replacement hire- please arrange for the above post at the earliest. Roles and Responsibilities Job Description: Assistant Manager - Quality Assurance, Environment and Energy - Certification Body Objective : The Assistant Manager - Quality Assurance (QA) for Environment & Energy ensures compliance with international accreditation standards, maintains robust Quality Management Systems (QMS), and supports the effective execution of validation, verification, and certification processes for climate change and GHG-related schemes Key duties: Ensuring the quality of project delivery for Climate Change and GHG projects under CB/VVB Maintaining and updating documentation for Climate Change project schemes and operating scheme owners’ platforms such as A6.4/CDM, VCS, GS, and GCC Maintaining accreditations and handling accreditation audits conducted by UNFCCC, NABCB, TV SD Corporate, and Climate Change scheme owners such as A6.4, GCC, and Verra. Providing support in the development and maintenance of TV SD’s own standards, frameworks, guidelines, forms, formats, training and procedures to ensure effective operationalization by CB/VVB. Creating forms, formats, and procedures as required by relevant Climate Change schemes, including document control. Maintaining and updating QA manuals, procedures, forms, and work instructions for validation, verification, and certification processes Ensuring QMS implementation for validation, verification, and certification activities at a global level. Maintaining and supporting the execution of CB/VVB’s planned activities. Planning for the monitoring of qualified personnel and ensuring their qualification status remains up-to-date in coordination with relevant functions. Ensure processing and timely payment of fees to relevant scheme owners like, Verra, UNFCCC, GS, GCC, NABCB etc. Providing supports in Internal Audits & external audits. Processing of new qualification requests Communication with accreditation bodies and relevant stakeholders for administrative related works. Capabilities: Intercultural competence. Fluency in English Socially adept with excellent time management and organization. Strong communication and excellent command over IT tools & systems. Knowledge of Climate Change related Policies, reporting standards like GHG Protocol, UNFCCC guidance, IPCC Guidelines etc. Should have excellent communication and presentation skills and should be able to liaison and coordinate internally & externally Preferred Qualification : A University degree or equivalent in the field of engineering, natural science, or related discipline Work Experience 5-10 years’ of work experience as Quality officer or relevant experience in the field of Environment/Quality Management systems or Climate change/Carbon credit Employment Type: Full-time Location: Onsite Pune corporate office Salary: Commensurate with experience.

Job Purpose : (what contribution is this position supposed to make in business?) The QMS and EU MDR Compliance Executive is responsible for ensuring compliance with ISO 13485, EU MDR (Regulation EU 2017/745), and other applicable quality and regulatory requirements. This role will support the development, implementation, and maintenance of the Quality Management System (QMS), oversee documentation control, conduct internal audits, and support regulatory submissions and audits as required. Key Deliverables/Responsibilities of this position 1- Quality Management System (QMS): Maintain and improve the ISO 9001:2015 / ISO 13485:2016-compliant Quality Management System. Ensure effective implementation of quality procedures and policies. Manage document control, change control, CAPA, non-conformances, and risk management processes. Coordinate internal audits, supplier audits, and management reviews. Monitor key quality metrics and report quality performance. 2- EU MDR Compliance: Ensure ongoing compliance with EU Medical Device Regulation (EU MDR 2017/745). Support the preparation and maintenance of technical documentation in accordance with Annex II and III of EU MDR. Work with cross-functional teams to ensure products meet General Safety and Performance Requirements (GSPRs). Coordinate with Notified Bodies during audits and technical file reviews. Support UDI, PMS (Post-Market Surveillance), and vigilance processes under EU MDR. 3- Regulatory Affairs: Assist with regulatory submissions and CE marking activities. Maintain up-to-date knowledge of applicable regulatory requirements and changes. Liaise with regulatory consultants, Notified Bodies, and competent authorities as needed. 4- Assist in compilation of technical files & related documentation: • Preclinical studies • Usability engineering as per EN 62366 • Risk management reports – as per 14971 • Clinical evaluation reports – as per MEDDEV 2.7.1 5- Knowledge of EU Regulation (EU) 2017/745, to prepare & compile: • Post Market Clinical Follow up (PMCF) • It is the requirement of EU MDR, Annex XIV • PMCF shall be understood to be a continuous process that updates the clinical evaluation • Post Market Surveillance (PMS) • It is the requirement of EU MDR • Labelling requirements • It Is related to Labeling requirements of medical devices as per EU MDR. Means candidate must understand the related requirements & standard knowledge. • UDI requirement. • It Is also related to Labeling requirements of medical devices as per EU MDR. UDI is the new requirement which must be present in CE certified product labels. • Unique device Identification. 6- Preparation and amendments of quality system procedures 7- Assist in external audits & internal audits 8- Knowledge of Quality Control Operations & Problem Solving & Continuous Improvement Required Technical Skills: Knowledge of ISO 13485 & Regulation (EU) 2017/745 Required Behavioural Attributes: Good learner Interactive with team Good communication skills

Role & responsibilities 1. Establishment and implementation of harmonized Quality Management Systems at all API plants. 2. To perform Self-Inspection and routine audit in all the API plants, R&D and subsidiaries of Akums. 3. To ensure compliance as per current regulatory requirements at all the API plants, R&D and subsidiaries of Akums. 4. Preparation, review and implementation of CQA SOP's at all API Plants of Akums. 5. To involve in regulatory audits along with site team and to ensure compliance submission within timeline. 6. To review investigation for elimination of Market complaints and support plant team to handle market complaints. 7. To co-ordinate and organize Corporate Quality Management Review meeting of API plants of Akums. 8. To raise queries and discussion with senior to resolve queries on daily basis. 9. SOP validation & implementation Preferred candidate profile • CQA Experience in Pharma- API industry will be preferred • Must have good understanding about WHO GMP Perks and benefits Salary no bar for deserving candidates.

Quality Mgr (must Grey / Iron casting- Pillaipakkam (Foundry Divi) Exp: 15+yrs Edu: Diploma/ BE Short notice preferable Interview date:19th Jul(Saturday) PAP, CFT,APQP,Heat treatment,Quality stand. CV- lifeturnmgmt6@gmail.com /7358656750 - What app

Requirement for Injection Molding Company Responsibilities: * Lead QMS implementation & maintenance * Ensure compliance with ISO, IATF standards * Manage PPAP documentation process * Oversee quality control activities

The Production Engineer is responsible for ensuring that production targets are met with quality while maintaining employee morale and safety.

Responsibilities: * Ensure compliance with IATF standards. * Develop & implement QMS policies & procedures. * Conduct regular audits & assessments. * Train staff on quality systems best practices. Provident fund

Role & responsibilities The ideal candidate would have experience in implementing and maintaining IMS (covering Quality, Environment, Health & Safety, etc.), along with strong compliance and auditing skills. Preferred candidate profile

Engr Quality-QC of MAJOR- MACHINED Parts of Compressor or Engine Parts MNC-5 day week BE Mechanical 5-6 yr exp in prepare QP’s Inspection procedures for MACHINED components, Crankshaft, Piston, Engine parts Some knowledge of ASME (MS /SS) IS codes Required Candidate profile QMS Implementaton, vendor inspection of MACHINED PARTS of Compressor/Engine + exposure of QC of welded parts Appraisal on product acceptances, product deviations, customer complaints Salary 7-8 lac pa