Quality Assurance Manager

Job Description:

Quality Assurance Manager

Job Summary: Our client is seeking a Quality Assurance Manager responsible for developing and implementing policies and procedures to support custom procedure tray manufacturing Quality System in accordance with 21 CFR Part 820 and other applicable regulations. This pivotal role focuses on ensuring compliance with customer and regulatory requirements by fostering a strong culture of quality.

• Quality Management System Oversight: Establish and maintain a Quality Management System compliant with 21 CFR Part 820. Review and approve quality system documents, reports, and records.
• Quality Reporting and Process Improvement: Ensure Quality Records are established and available as per regulations. Implement and oversee Process Controls and Quality Controls throughout the production process.
• Supplier Qualification, Internal Audits, and CAPA Management: Oversee supplier qualification processes. Conduct internal audits and manage Corrective and Preventive Action (CAPA) processes.
• People Management: Supervise and lead Quality Assurance Technicians and Quality Control Technicians.

• Education: BA/BS in sciences, engineering preferred.
• Experience: Minimum 5 years proven experience in the medical device industry. Minimum 2 years of experience in a supervisory or management role.

• Reports to: Executive Director Quality and Regulatory.
• Full-Time Employees (FTE's): 9.
• Top 3 Objectives:
  • Ensure ongoing compliance with FDA requirements while optimizing the quality system and transitioning to ISO 13485.
  • Collaborate with Operations to reduce in-process defects, customer complaints, and recalls, ensuring high-quality product delivery.
  • Develop a strong culture of Quality across all departments, facilitating and supporting growth.
• Reason for Vacancy: New Position
• Must-Have Attributes:
  • Ability to collaborate across departments.
  • Friendly and professional demeanor.
  • Capability to make decisions that may impact Operations or Financials.

Our client is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.