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.

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This role will be posted for a minimum of 3 days.