Quality Manager
Phillips Medisize, a Molex Company, is seeking a contribution-motivated Quality Manager to join our manufacturing campus in Menomonie, WI. You will create value by stewarding Sustaining Quality with your background in medical device and pharmaceutical quality assurance, a passion for ensuring the highest standards in product quality and compliance, and a commitment to excellence.
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.
What You Will Do
- 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
- Provide coaching and development to your team of leaders, 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 Key Performance Indicators (KPIs) and drive improvement
- Ensure compliance with cGMP, cGMP, and regulatory requirements
- Ensure proper establishment of requirements and ongoing compliance for drug handling and associated laboratory operations
- 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
Who You Are (Basic Qualifications)
Bachelor's degree or higher in a scientific discipline7+ years of experience in Quality Assurance within the pharmaceutical, medical device, or biotechnology industry10+ years of management experienceProficiency in quality management tools, technical writing, methodologies (e.g., risk assessment, root cause analysis, FMEA)Strong analytical skills for data analysis and trend identificationExperience in packaging, serialization, sterilization, drug product manufacturing and complaint handlingProven expertise in managing FDA inspections, audits, and developing effective response strategiesWhat Will Put You Ahead
Highly competent working knowledge of ICH and relevant CFRs and other industry guidelinesProven experience in GxP audits, quality management systems, and CAPAsCompetency in statistical tools and process validationEffective cross-functional collaborator with teams such as Regulatory Affairs and CMC (Chemistry, Manufacturing, and Controls)Our 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 - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation / time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter.
Equal Opportunities
Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please click here for additional information.