We are seeking a Quality Assurance Manager to play a crucial role in the development and implementation of policies and procedures supporting the Quality System for custom procedure tray manufacturing. The candidate will ensure compliance with 21 CFR Part 820 and other relevant regulations, fostering a culture of quality to meet both customer and regulatory requirements.
- Oversight of the Quality Management System
- Quality Reporting and Process Improvement
- Supplier Qualification, Internal Audits, and CAPA Management
- Establish and maintain a 21 CFR Part 820-compliant Quality Management System, reviewing and approving relevant documents, reports, and records.
- Ensure the availability of Quality Records as required by 21 CFR Part 820 and the Quality System, with a focus on compliance with 21 CFR Part 11 for electronic records and signatures.
- Define and implement Process Controls and Quality Controls throughout the production process to meet customer and regulatory standards.
- Collect, analyze, and trend quality data, providing evidence-based recommendations for process improvements in reports.
- Supervise Quality Assurance Technicians and Quality Control Technicians.
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 the delivery of high-quality products.
- Develop a strong culture of Quality across all facility departments to facilitate and support growth.
Reason for Vacancy: New Position
Who Will Be a Great Fit?
The ideal candidate must collaborate effectively with various departments, maintaining a friendly and professional demeanor while making decisions that may impact Operations or Financials negatively.
- BA/BS in sciences, engineering preferred
- Minimum 5 years of proven QA experience in the medical device industry
- Minimum 2 years of experience in a supervisory or management role
- 21 CFR Part 820