Quality Leader – Medical Devices (FDA/cGMP)

Phillips Medisize; Costa Mesa (CA); On-site; USD 100,000 - 135,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Flexible spending accounts

Health savings accounts

Life insurance

Disability insurance

Retirement plan

Paid vacation/time off

Educational assistance

Infertility assistance

Paid parental leave

Adoption assistance

Job summary

Phillips Medisize, a Molex Company, is seeking a contribution-motivated Quality Manager to join our manufacturing site in Costa Mesa, California.

You will create value by stewarding Quality with your background in medical device quality assurance, a passion for ensuring the highest standards in product quality and compliance, and a commitment to excellence.You will lead a team, support day-to-day manufacturing operations, manage FDA inspections, drive improvement, and ensure compliance with cGMP

Qualifications

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

Responsibilities

• Ensure compliance with regulatory requirements and internal procedures including notified body and regulatory inspection support.
• Communicate and demonstrate a vision for a culture of quality, through performing at both the strategic and tactical levels.
• Support quality functions of day-to-day manufacturing operations and engineering efforts.
• Provide coaching and development to your team and ensure your entire organization is leveraging its individual and collective comparative advantage.
• Serve as the Management Representative, whose primary responsibility is to ensure that the facility meets internal policies and requirements, customer requirements, and divisional quality systems.
• Monitor KPIs and drive improvement.
• Ensure compliance with cGMP, and regulatory requirements.
• Act as a communication liaison between the customer and manufacturing facility.
• Participate and drive continual improvement/innovation, corrective action and internal/external customer satisfaction.
• Actively contribute to a safe and inclusive workplace environment.

Skills

Quality Assurance

Team Leadership

Risk Assessment

FMEA

Root Cause Analysis

Data Analytics

FDA Inspections

Education

Bachelor's degree in science

Job description

Phillips Medisize, a Molex Company, is seeking a contribution-motivated Quality Manager to join our manufacturing site in Costa Mesa, California.

You will create value by stewarding Quality with your background in medical device quality assurance, a passion for ensuring the highest standards in product quality and compliance, and a commitment to excellence.You will lead a team, support day-to-day manufacturing operations, manage FDA inspections, drive improvement, and ensure compliance with cGMP