Quality Engineer - QMS

Looking Quality Engg for Highly reputed Product based MNC in Medical domain based out of Gurgaon

 

Role And Responsibilities :-

 

Ø  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

Ø  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

Ø  Will support vendor management issues. Related to

·         Quality Management System

·         Vendor Audits

·         Vendors assessment & Management     

·         Vendor partners Training       

Ø  Will work as training co-ordinator for the QMS. Related to

·         Quality Management System

·         Ensure effective closure, by working with auditees to ensure comprehension, development, and execution of corrective/preventive action with regards to any nonconformities cited during audits.

·         Identify areas of opportunity and support continual improvement of the Quality Management System

·         Identify, develop, and report QMS metrics.

Ø  Will work as Management Review co-ordinator for the QMS. Related to

·         Conduct of the MRM

·         MRM Agenda Control

·         MRM records

 

Technical Skill

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 development 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.

 

Education:

• B.Tech/B.E/M.Tech/MS. -  Mechanical Engineering

Ø  Experience: 3-6 years