The purpose of the Manager QA for Post Market is to provide leadership as the designated function for managing and establishing the necessary Medical Device Post-Market Surveillance and Quality System requirements to ensure compliance to all applicable domestic and international regulations.
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Lead and manage the QA Post-Market Team that is responsible for the receipt, documentation, investigation, resolution, and trending of customer complaints to ensure regulatory compliance and customer satisfaction
- Oversees the team responsible for determining and processing medical device adverse event and incident reporting requirements compliant with federal and international regulations.
- Responsible for escalating and facilitating product correction and removals (recalls, market withdrawals and stock retrievals) to ensure regulatory compliance and patient safety.
- Interface with distributors, sales force, international representatives and in-house departments for complaint, adverse event and incident reporting training and information.
- Responsible with communication to the FDA and international regulatory agencies for post-market surveillance activities (i.e., complaints, global adverse event and incident reporting). Providing training to employees, sales agents, sales representatives and customers regarding the regulatory requirements for complaint handling, adverse event reporting, corrections and removals, and corrective and preventive actions.
- Leading or participating in Regulatory and QMS audits (internal or external) to achieve successful audit outcomes.
- Ensuring that company procedures, processes and documentation meet the required guidelines for maintaining global compliance.
- Develop, monitor and maintain adequate systems to analyze and trend post-market data.
- Practice leadership as stated in the Exactech Leadership Model
- Ensure organizational alignment in the design and execution of initiative efforts
- Establishes clearly defined individual goals
- Provide leadership to include effective feedback on culture, results and future, coaching and mentoring, performance management and career development
- Assure compliance to the code of ethics
- Knowing and applying Exactech’s Quality System and any appropriate federal and international standards.
- Assisting and supporting other employees, teams, and sales personnel as necessary.
Education:
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Bachelor’s Degree in a related field from an accredited institution required.
Experience:
- Extensive background in Medical Device Post-Market Surveillance or have the qualifications to make medical judgments preferred.
- Minimum 7 years’ experience in global medical device quality management system required.
- Minimum 7 years’ experience in global adverse event reporting requirements.
- Previous experience in complaint trending and complaint trend analysis
- Orthopedic device industry preferred.
Functional/Technical Knowledge, Skills and Abilities Required:
- Previous supervisory or management experience required.
- Technical writing skills required.
- Working knowledge of windows-based office productivity tools including word processor and spreadsheet.
- Preferred familiarity with a Quality Management Software solution (Trackwise, SmartSolve, etc.).
About Exactech
Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com for more information and connect with us on LinkedIn, VuMedi, YouTube, Twitter and Instagram.