Job Description

Job Description

Job Description

Description:

Position Summary

The Quality Assurance (QA) Supervisor is responsible for overseeing the quality control operations within the medical device manufacturing environment to ensure compliance with all applicable regulatory requirements, including FDA regulations (21 CFR Part 820), ISO 13485, and internal quality standards. This role provides leadership and direction to the QA Technician group, ensuring that products meet established quality specifications and company objectives for safety, efficacy, and performance.

The QA Supervisor will coordinate day-to-day activities related to product and raw material inspection, device history record reviews, release of product for distribution, environmental monitoring of the cleanroom environments, and product testing. The QA Supervisor will assist in the nonconformance process and serve as QA representative for the Material Review Board.

Job Duties/Responsibilities

• Supervise and coordinate all incoming, in-process, and final inspection/testing activities for medical device components and finished goods.
• Ensure compliance with quality assurance procedures, specifications, and regulatory standards.
• Coordinate and assist with process audits to ensure compliance with procedures and regulations.
• Review and approve inspection records, test data, batch records, and device history records (DHRs) prior to product release.
• Train, evaluate, and mentor the QA Technician group, ensuring proficiency in inspection techniques, documentation review, and regulatory compliance.
• Support investigations of nonconformances and product quality issues, contributing to root cause analysis and corrective actions.
• Coordinate equipment calibrations and review and approval of calibration and maintenance records.
• Coordinate environmental monitoring of the cleanrooms.
• Collaborate with cross-functional teams to support process validations and quality improvements.
• Prepare QA metrics and reports to monitor department performance and support management review.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in a scientific, technical, or engineering discipline, or equivalent experience preferred.
• Minimum of 3–5 years of experience in Quality Control within the medical device or regulated life sciences industry.
• Strong understanding of FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices (GMP).
• Prior experience supervising or leading inspection or testing teams is preferred.
• Familiarity with measurement tools, inspection methods, and quality data analysis.
• Excellent attention to detail, organizational skills, and ability to work in a fast-paced, regulated environment.
• Ability to operate and communicate effectively with cross-functional teams.
• Strong analytical and problem-solving skills.
• Ability to multi-task and work within deadlines.
• Must be detail oriented with the ability to work both independently and as a part of a dynamic team.
• Ability to establish and maintain effective working relationships relevant with cross functional teams.
• Excellent written and verbal communication skills.
• Proficient in using Microsoft office programs (Word, Excel, and PowerPoint).
• Willingness to work a flexible schedule.
• Able to travel for work as needed.
• Satisfactorily pass comprehensive background screening.

Physical Demands/Working Conditions

• Works in office space, supply room, laboratory, and/or clean room environments.
• Frequent exposure to hazardous materials requiring appropriate PPE and precautions when working with hazardous materials and chemicals.
• Frequent use of a computer, keyboard, mouse, monitor and other office equipment.
• Frequently picks up, carries, and moves items up to 50 lbs.
• Some evening and weekend work depending upon workload.
• Some overnight travel may be required for work, events, and training.

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