Work Flexibility: Hybrid
Position Summary
Ensure timely closure of complaint 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.
Key Areas of Responsibility
* 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.
* Attend job-pertinent training classes.
Qualifications/Knowledge/Skills
* Bachelor's Degree in Engineering or related field of study.
* 3+ years' experience in the Medical Device Industry; preferably in Post-Market Surveillance.
* Demonstrated applied knowledge of regulatory requirements: ISO 9001 or ISO 13485, Quality System Regulation, and Medical Device Directive
* Demonstrated ability to manage and lead complex or broad scope projects
* Demonstrated ability to deliver positive, energetic support to a team, and to be an advocate for product excellence and quality
* Demonstrated results orientation, multi-tasker, and quick learner; demonstrated ability to respond to the urgent needs of the team and track record of meeting agreed upon deadlines
* Demonstrated verbal, written and interpersonal skills.
* Demonstrated problem solving and troubleshooting skills.
* Applied knowledge of Microsoft Office software including Excel, Word and Power Point.
#IJ
Travel Percentage: 10%