Quality Assurance Supervisor
1 month ago
Envista Holdings Corporation is seeking a highly skilled Quality Assurance Supervisor to join our team. As a key member of our quality team, you will be responsible for leading the Complaint Handling/Post-Market Surveillance (PMS) team to provide post-market data for product and process improvement initiatives.
Key Responsibilities:- Lead the Complaint Handling/PMS team to ensure compliance with regulatory requirements and internal procedures.
- Conduct thorough investigations into reported complaints, collaborating with cross-functional teams to ensure complaint data accuracy, identify root causes, assess potential risks, and implement corrective and preventive actions.
- Maintain accurate and comprehensive records of all complaints, investigations, incident/event reportable, and resolutions.
- Stay updated with relevant regulations and standards (e.g., FDA, ISO) and ensure that complaint handling processes align with regulatory requirements.
- Collaborate with Tech Support, Customer Service, Engineering, Quality Assurance, and Regulatory Affairs teams to assess trends, identify areas for improvement, and contribute to the development of quality systems and processes.
- Bachelor's degree in a relevant field (e.g., Engineering, Life Science).
- Five or more years of experience in the Medical Device industry.
- At least two years of decision-making experience.
- One or more years of direct supervisory experience.
- Superior written, verbal, interpersonal communications; presentation skills are a huge plus.
- Strong knowledge of complaint processes and adverse event reporting.
- Excellent analytical skills with the ability to conduct thorough investigations and root cause analyses.
- SAP ERP and document control experience.
- Experience with Microsoft Dynamics CRM.
- Knowledge of GMP and Quality Systems in a regulated industry (medical device or pharmaceutical area).
Envista Holdings Corporation is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
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Quality Assurance Supervisor
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