Senior Quality Assurance Engineer

Post Market Surveillance Specialist

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