Flag this message 6 positions_QA_GURGAON, DELHI NCR neetu.goyal@tekishub.com

Experience required for Job: 5 - 12 years

Job Annual Salary: Not Mentioned

Job location: Delhi/NCR

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ob Title Quality Engineer - QMS
Job Description Note from Hiring Manager: 2 tickets will be for software where the candidate should have at least 2 years of experience in Embedded Programming with Total 6-10 years of Quality experience. Rest 3 tickets will be for Mechanical domain with (3-10) years of experience AND people from Mechanical background (BE- Mechanical/ Production/ Instrument).

Roles and Responsibilities
• Will assist in planning and conduct of the Internal audits
• Internal auditor training plan
• Audit Planning
• Audit checklist preparation and control
• Conduct the Internal Audits
• Audit results formalization and closer
• Will assist in development of QMS procedures and forms
• Based on the requirements of ISO13485, ISO14971 and 21 CFR 820 requirements
• Documents and Records control
• Will support vendor management issues. Related to
• Quality Management System
• Vendor Audits
• Vendors assessment & Management
• Vendor partners Training
• Will work as training co-ordinator for the QMS. Related to
• Quality Management System
• Standards
• Ensure effective closure, by working with auditees to ensure comprehension, development, and execution of corrective/preventive action with regards to any nonconformities cited dur-ing audits.
• Identify areas of opportunity and support continual improvement of the Quality Management System
• Identify, develop, and report QMS metrics.
• Will work as Management Review co-ordinator for the QMS. Related to
• Conduct of the MRM
• MRM Agenda Control
• MRM records

Technical Skill Set
Primary
• Understanding of the concepts of 21CFR 820, ISO13485, ISO14971, ISO9001, PPAP, APQP, MSA, SPC, FMEA, Process Capability, Complaint Handling, Supplier assessment & control, Data analysis, Measurement systems, Understanding of Design system and ability to train others in these concepts.



Additional
• Trained internal auditor on ISO9001/ISO13485/ TS16949.
• Demonstrated experience in developing quality management systems; design and develop-ment of training programs/courses;
• Demonstrated auditing experience in medical device manufacturing environment.
• Applied understanding of CGMPs, ISO 9001 & ISO 13485.
• Demonstrated ability to effectively advocate a strategic quality systems approach and ensure compliance.
• Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies.
• Demonstrated leadership ability and experience.
• Demonstrated PC proficiency.
• Demonstrated organizational and written/verbal communication skills.
• Demonstrated ability to self-motivate
• Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.
• Demonstrated ability to prioritize tasks in a deadline-driven environment.

Desired Profile
Education:
• B.Tech/B.E/M.Tech/MS. - Mechanical Engineering

Regrads
Neetu