Quality Manager - Medical Devices & Compliance

Koch Business Solutions, LP; Costa Mesa (CA); On-site; USD 100,000 - 135,000; Full time

Job summary

Phillips Medisize, a Molex Company, is seeking a Quality Manager at our Costa Mesa, California site. You will steward quality across manufacturing with a strong focus on medical device standards, risk management, and regulatory readiness.

You will lead a team, drive KPI-based improvements, and partner with operations and regulatory affairs to ensure top-tier product quality and compliance while fostering a safe, inclusive workplace.

Qualifications

• 5+ years of experience in Quality Assurance within the manufacturing industry.
• 2+ years leading, developing, and managing teams in a manufacturing or regulated environment.
• Experience with quality management tools, risk assessment, methodologies (e.g., FMEA).
• Strong analytical skills with data analysis and trend identification.
• Proven expertise in managing FDA inspections, audits, and developing effective responses.

Responsibilities

• Ensure compliance with regulatory requirements and internal procedures including regulatory inspections.
• Communicate and demonstrate a culture of quality at strategic and tactical levels.
• Support quality functions of day-to-day manufacturing operations and engineering efforts.
• Coach and develop your team to leverage organizational strengths.
• Serve as Management Representative to ensure the facility meets policies and customer requirements.
• Monitor KPIs and drive improvement.
• Ensure CGMP compliance and regulatory requirements.
• Act as liaison between customer and facility.
• Drive continual improvement, CAPAs and customer satisfaction.
• Foster a safe and inclusive workplace environment.

Skills

Quality Assurance

Team leadership

Data analysis

FDA inspections

Regulatory knowledge

Education

Bachelor's degree in a scientific discipline

Tools

FMEA

Quality management systems

Job description

Phillips Medisize, a Molex Company, is seeking a Quality Manager at our Costa Mesa, California site. You will steward quality across manufacturing with a strong focus on medical device standards, risk management, and regulatory readiness.

You will lead a team, drive KPI-based improvements, and partner with operations and regulatory affairs to ensure top-tier product quality and compliance while fostering a safe, inclusive workplace.