Work Flexibility: Hybrid or Onsite

12 month hybrid contract with full Stryker benefits.

Ensure timely closure of complaints records to comply with FDA and other competent authorities ‘requirements; Monitor key process indicators and make suggestions on areas requiring increased focus to management. Mentor, oversee and approve the work of other team members.

What you will do:

• Work in a team environment with members of the Post market intelligence group on achieving team metrics requirements.
•Ensure timely, accurate and complete failure investigations of product complaints leading to root cause and corrective/preventive action.
• Organize a cross functional team to help identify problem issue and drive product improvement process.
• Provide support to the new product development and risk management process.
•Work with all products, manufacturing and quality teams to determine root cause and to ensure proper corrective actions have been identified, implemented and verified to be effective.
•Participate and lead in continuous improvement and process re-engineering projects in support of Stryker Orthopaedics' continuous improvement initiatives.
• Perform engineering analysis to determine root cause and corrective action.

What you will need:
• 2+ years’ experience in the Medical Device Industry; preferably in Post-Market Surveillance.

• Level 8 Degree in Engineering, Sciences.
• Demonstrated applied knowledge of regulatory requirements: ISO 9001 or ISO 13485, Quality System Regulation, and Medical Device Directive.

Travel Percentage: None

Senior Quality Assurance Engineer

Benefits

Job Description