Quality Manager - Medical Devices | Leadership & Compliance

Flint Hills Resources; Costa Mesa (CA); On-site; USD 100,000 - 135,000; Full time

Job summary

Phillips Medisize, a Molex Company, seeks a contribution-motivated Quality Manager to join our Costa Mesa site in California. You will steward quality across manufacturing with a focus on medical device quality assurance and compliance.

You will lead a team, partner with operations and engineering, and drive cGMP compliance, regulatory readiness, and continuous improvement while ensuring safe and inclusive workplaces.

Qualifications

• 5+ years of QA experience in manufacturing.
• 2+ years leading teams in a regulated environment.
• Experience with QMS, CAPAs, risk assessment, and FMEA.
• Strong data analysis and trend identification.
• Experience managing FDA inspections and audits.

Responsibilities

• Ensure regulatory compliance and support inspections.
• Communicate a culture of quality at strategic and tactical levels.
• Support day-to-day manufacturing quality and engineering.
• Coach and develop the QA team.
• Serve as Management Representative for quality systems.
• Monitor KPIs and drive improvements.
• Ensure cGMP and regulatory requirements.
• Act as liaison between customer and facility.
• Drive continual improvement and safety.

Skills

Quality Assurance

Leadership

Regulatory Compliance

Data Analysis

FDA Inspections

Education

Bachelor's degree in scientific discipline

Job description

Phillips Medisize, a Molex Company, seeks a contribution-motivated Quality Manager to join our Costa Mesa site in California. You will steward quality across manufacturing with a focus on medical device quality assurance and compliance.

You will lead a team, partner with operations and engineering, and drive cGMP compliance, regulatory readiness, and continuous improvement while ensuring safe and inclusive workplaces.