Quality Manager

Phillips Medisize, a Molex Company, is seeking a contribution-motivated Quality Manager to join our manufacturing site in Costa Mesa, California. You will steward Quality with your background in medical device quality assurance, ensuring the highest standards in product quality and compliance.

About the Team

Phillips Medisize is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics, and medical device industries. We work collaboratively within our Global Quality Organization to deliver compliant and effective solutions to our customers.

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, ensuring the facility meets internal policies, customer requirements, and divisional quality systems
• Monitor Key Performance Indicators (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, corrective action, and internal/external customer satisfaction
• Actively contribute to a safe and inclusive workplace environment

Requirements

• 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

Qualifications

• Bachelor’s degree or higher in a scientific discipline
• Proven experience in GxP audits, quality management systems, and CAPAs
• Competency in statistical tools and process validation
• Effective cross-functional collaborator with teams such as Operations, Engineering, Regulatory Affairs

Pay

For this role, we anticipate paying $100,000 - $135,000 per year. This role is eligible for variable pay, issued as a monetary bonus or in another form.

Benefits

Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength. Our benefits plan includes:

• Medical, dental, vision, flexible spending and health savings accounts
• Life insurance, ADD, disability, retirement
• Paid vacation/time off, educational assistance
• May also include infertility assistance, paid parental leave, and adoption assistance