Senior Quality Assurance Engineer

Work Flexibility: Hybrid or Onsite<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>12 month hybrid contract with full Stryker benefits. </b></p><p><br />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.</p><p><br /><b>What you will do:</b></p><p>• Work in a team environment with members of the Post market intelligence group on achieving team metrics requirements.<br />•Ensure timely, accurate and complete failure investigations of product complaints leading to root cause and corrective/preventive action.<br />• Organize a cross functional team to help identify problem issue and drive product improvement process.<br />• Provide support to the new product development and risk management process.<br />•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.<br />•Participate and lead in continuous improvement and process re-engineering projects in support of Stryker Orthopaedics&#39; continuous improvement initiatives.<br />• Perform engineering analysis to determine root cause and corrective action.<br /> </p><p><b>What you will need: </b><br />• 2&#43; years’ experience in the Medical Device Industry; preferably in Post-Market Surveillance.</p><p>• Level 8 Degree in Engineering, Sciences.<br />• Demonstrated applied knowledge of regulatory requirements: ISO 9001 or ISO 13485, Quality System Regulation, and Medical Device Directive.</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: None<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>