Team Lead-QMS in Gurugram at Stryker Corporation

Date Posted: 9/25/2018

Job Snapshot

Job Description

Job Responsibilities:


  • Lead Audit Planning, Scheduling and conduct internal audits
  • Lead opening meeting, Closure meetings, audit results formalization and closer
  • Lead Corporate audit and all external audits are complete
  • Guide the team in development of QMS procedures and forms based on the requirements of ISO13485, ISO14971 and 21 CFR 820 requirements
  • Act as a Project coordinator to review the project deliverables to ensure compliance to the defined processes
  • Management Review coordinator for the QMS. Related to Conduct of the MRM and keep up the records
  • Ensure effective closure, by working with auditees to ensure comprehension, development, and execution of corrective/preventive action with regards to any non-conformities cited during audits.
  • Will ensure compliance to GDP and Quality Management System requirements
  • Knowledge of NPDP process/APQP/PPAP activities
  • Design review: Sound Knowledge of Drawing interpretation and basics of GD&T
  • Risk Analysis: Sound Knowledge of FMEA (Process & Design)/Control Plans
  • Validation support for product, processes, packaging, sterilization
  • Identify areas of opportunity and support continual improvement of the Quality Management System
  • Assist and perform Vendor/ supplier Audits

Skill Set

  •  Trained Internal/ Lead auditor on ISO 13485
  •  Demonstrated experience in developing quality management systems; design and development of training programs/courses;
  •  Demonstrated auditing experience in a manufacturing environment.
  •  Applied understanding of GDP, ISO 9001 & ISO 13485
  • Hands on experience of Conducting Management Review Meetings
  • Demonstrated ability to effectively advocate a strategic quality systems approach and ensure compliance
  • Hands on experience on Product development and Risk Management
  • Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies.
  • Demonstrated organizational and written/verbal communication skills.
  • Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.
  • Medical Devices domain experience is desirable.

Education:

B. Tech / B.E/ M. Tech/MS. – Mechanical

Experience:

                     8-10 years

Work From Home: No

Travel Percentage: Up to 25%

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