Quality Assurance Manager

4 weeks ago

Quakertown, Pennsylvania, United States enVista Full time
Job Description:

At enVista, we are seeking a highly skilled Quality Assurance Manager to lead our Quality Engineering and Complaint Handling/Post-Market Surveillance teams. As a key member of our organization, you will be responsible for executing quality strategies for sustaining and new products, as well as supervising and coaching the work of staff in this area.

Key Responsibilities:
  • Oversee end-to-end process of receiving, reviewing, documenting, investigating, and resolving complaints related to our medical devices in compliance with regulatory requirements and within process timeframes.
  • Analyze and report on KPIs related to supplier and product quality and oversee initiatives to drive to KPI targets.
  • 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 (CAPAs).
  • Maintain accurate and comprehensive records of all complaints, investigations, incident/event reportable, and resolutions, ensuring adherence to regulatory standards and internal procedures.
  • Stay updated with relevant regulations and standards (e.g., FDA, ISO) and ensure that quality 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.
  • Prepare and present reports on complaint trends, investigation outcomes, and risk assessments to internal stakeholders and regulatory agencies as necessary.
  • Maintain and drive improvements of the supplier quality management program.
  • Oversee management of supplier files, including oversight and review of the Approved Suppliers List.
  • Manage and support supplier audits.
  • Manage and support the issuance and review of Supplier Corrective Action Requests, reviewing for accuracy and confirming effectiveness of the Corrective Action.
  • Oversee the internal non-conforming parts/products process and the Material Review Board.
  • Utilize established business tools (EBS) to drive continuous improvement of processes to further streamline and automate complaint data processing.
  • Identify, initiate, and support product quality initiatives.
  • Train Quality Assurance Specialists and other team members.
Requirements:
  • Bachelor's degree; preferably in Engineering, Life Science, or similar technical field.
  • Five (5) or more years of experience in the medical device industry.
  • At least four (4) years of decision-making experience.
  • Three (3) or more years of direct supervisory experience.
  • Knowledge of FDA regulations, ISO 13485 MDSAP, EU MDR.
  • Proficient use of computers, MS-Office (Word, PowerPoint, and Excel knowledge required).
  • Capable of communicating with clarity within team, cross-functional departments, and management.
  • Capable of making decisions for day-to-day activities.
  • Demonstrated ability to teach and mentor.
  • Ability to analyze and assimilate data including engineering drawings, specifications, labeling, statutory and regulatory requirements.
  • Self-motivated and able to work with minimum supervision.
Preferred Qualifications:
  • Experience with FDA regulations, ISO 13485 MDSAP, EU MDR.
  • 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).
  • Exceptional organizational skills and attention to detail to maintain accurate documentation and records.
  • Effective interpersonal and communication skills with the ability to collaborate cross-functionally, interact with customers professionally and empathetically, and work with minimum supervision.
  • Certification in quality management (e.g., Certified Quality Auditor - CQA) is a plus.

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