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%