HR Professional at Stryker
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Stryker - Team Lead - Quality Management System (8-12 yrs)
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 : 8-12 years
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