Quality Manager

Your Job

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.

Our 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.

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 discipline


* 7+ years of experience in Quality Assurance within the pharmaceutical, medical device, or biotechnology industry


* 10+ years of management experience


* Proficiency in quality management tools, technical writing, methodologies (e.g., risk assessment, root cause analysis, FMEA)


* Strong analytical skills for data analysis and trend identification



* Experience in packaging, serialization, sterilization, drug product manufacturing and complaint handling


* Proven expertise in managing FDA inspections, audits, and developing effective response strategies

What Will Put You Ahead


* Highly competent working knowledge of ICH and relevant CFRs and other industry guidelines


* 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 Regul...