Our award-winning client is seeking a Quality Assurance Manager to join their team. Lead oversight of the Quality Management System, ensuring compliance with 21 CFR Part 820, validating electronic records per 21 CFR Part 11, implementing robust Process and Quality Controls, managing Quality Data, and providing leadership to a team of Quality Assurance and Control Technicians.

Responsibilities:

• Lead oversight of the Quality Management System with a focus on Quality Management System (QMS) Compliance: Establish and maintain a QMS compliant with 21 CFR Part 820.

• Review and approve quality system documents, reports, and records.

• Record Keeping: Ensure Quality Records are established and accessible per 21 CFR Part 820 and Quality System requirements.

• Validate electronic records and signatures for compliance with 21 CFR Part 11.

• Process and Quality Controls: Guarantee the definition and implementation of adequate Process Controls and Quality Controls throughout the production process.

• Ensure alignment with customer and regulatory requirements.

• Quality Data Management: Collect, analyze, and trend quality data.

• Provide quality performance data for reports and offer evidence-based recommendations for continuous process improvements.

• Supervision and Leadership: Supervise a team of Quality Assurance Technicians and Quality Control Technicians.

Required Qualifications:

• Education:

• Preferably holds a BA/BS in sciences, with a preference for engineering backgrounds.

• Experience:

• Demonstrates a minimum of 5 years of proven expertise in the medical device industry.

• Possesses a minimum of 2 years of experience in a supervisory or management role.