Quality Control (QC) Supervisor

Job Description

Job Description

Description:

 

The Quality Control Supervisor oversees the daily operations of the QC department to ensure all medical devices are inspected, tested, and documented in compliance with FDA 21 CFR Part 820, ISO 13485, and applicable regulatory requirements. This role provides leadership to QC inspectors, ensures adherence to quality standards, and works cross-functionally to support continuous improvement in manufacturing quality.

MUST HAVE METROLOGY AND BLUEPRINT EXPERIENCE.

This role will oversee a team of Quality Control Inspectors (Union roles).

Leadership & Oversight

• Supervise, train, and mentor QC inspectors, ensuring consistent application of inspection and testing procedures.
• Assign and monitor daily workloads, prioritizing tasks to meet production and shipping schedules.
• Foster a culture of quality, compliance, and accountability within the team.

Quality Control Operations

• Oversee inspection and testing of incoming materials, in-process components, and finished medical devices per established procedures and specifications.
• Review and approve inspection records, test results, and Certificates of Conformance.
• Establish Quality Inspection Plans and equipment needs to ensure proper process control is in place with Quality Assurance, Operations, and Engineering
• Ensure proper use and calibration of QC equipment, including measurement tools and test instruments.
• Support and lead efforts of Gage Repeatability and Reproducibility (Gage R&R) and Test Method Validation with manufacturing engineers
• Maintain control of nonconforming materials, including segregation, documentation, and disposition per established processes. Manage Material Review Board process to ensure reject parts are dispositioned appropriately.
• Drive Material Return process
• Supporting complaint investigation with inspection, test, documentation and implementation of Corrective/Preventive Actions.

Compliance & Documentation

• Ensure QC activities comply with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable standards.
• Generate and review quality records, inspection reports, and Device History Records (DHRs) for accuracy and completeness.
• Support internal and external audits by providing documentation and participating in audit activities.

Continuous Improvement

• Identify and report quality trends, defects, or process deviations to Quality and Manufacturing leadership.
• Collaborate with Engineering, Manufacturing, and Supply Chain to resolve quality issues and improve processes.
• Support Corrective and Preventive Actions (CAPA) and root cause investigations.

Skills, Qualifications, Competence Level Qualifications/education/Specialist Training required

ESSENTIAL

• · Organization
• · Strong written and verbal skills
• · Collaboration skills
• · QC process skills
• · Computer knowledge and skills (Microsoft suite)
• · Leadership
• DESIRABLE
• · eQMS skills
• · Knowledge of ISO 13485, MDSAP, 21 CFR 820, MDR 2017/745
• · Quality engineering (ASQ or similar Certifications)
• · Experience in various inspection methods and equipment

Requirements:

 

Experience Required

REQUIRED

• · Associates or Bachelors. Degree in an Engineering field is preferred (mechanical preferred).
• · 3-5 years’ experience in regulated medical device industry highly preferred.
• · Strong familiarity with calibration methods/standards, various gage use, and failed equipment risk analysis.
• · Strong knowledge of global Quality System regulations related Good Manufacturing Practices. (ISO 13485, 9001, 17025)
• · Legally authorized to work in the United States.

PREFERRED

• · Professional certification(s) relevant to the position preferred (e.g., CQA, CQM, and/or CQE).
• · Experience with electronic quality system documentation management and statistical tools such as GageTrak, MiniTab, Solidworks, CAD, PowerBI, Windchill, SAP, QPulse,etc.
• · Excellent written and verbal communication skills.
• · Project leadership skills.
• · Experience with quality inspection processes and equipment
• Knowledge of safety requirements and legal standards

Aptitude/Skill Required

REQUIRED

• · Organization
• · Strong written and verbal skills
• · Collaboration skills
• · Engineering process skills
• · Computer knowledge and skills (Microsoft Suite, Solidworks, CAD, Minitab or similar)

PREFERRED

• · eQMS skills
• · Knowledge of ISO 13485, MDSAP, 21 CFR 820, MDR 2017/745
• · Quality engineering (ASQ or similar Certifications)
• · Statistical Analysis