Quality Engineer

Your Job

Phillips Medisize, a Molex Company, is seeking a contribution -motivated Quality Engineer to join our Menomonie, WI site.

You will create value by stewarding New Product Introductions (NPI) with your background in Medical Device Quality Assurance and Validation to ensure new projects/programs meet customer, regulatory, and manufacturing requirements, 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 with our Global Quality Organization to deliver compliant and effective solutions to our customers.

What You Will Do


* Lead validation and quality assurance activities for NPI projects.



* Work with project teams and customers to define validation requirements and strategy.



* Develop and maintain quality plans for new medical device product introductions.



* Ensure program compliance with regulatory requirements, including FDA (21 CFR 4, 11, 210, 211, 820), GMP, ISO 13485, etc.



* Draft and control validation documentation, including Master Validation Plans, protocols, deviations, and summary reports.



* Manage and oversee quality/validation documentation, including risk management, specifications, part approval, and work instructions.



* Drive execution of computer system/software, test method, equipment, and process validation activities.



* Facilitate root cause investigations and corrective actions during product launch.



* Stay informed of industry trends and regulatory updates to ensure compliance and competitiveness.



* Share best practices and drive continuous improvement efforts to enhance program validation, product quality, and manufacturing processes.



* Support global Quality Systems and Validation requirements through audits and inspections to ensure compliance with internal and external quality standards.



* Assist with documentation and audit readiness for regulatory body and customer audits.



* Travel to other Wisconsin Phillips Medisize sites (up to 50%) with occasional travel outside Wisconsin as needed.



* Other duties as assigned

Who You Are (Basic Qualifications)


* Bachelor's degree in engineering, Quality, Life Sciences, or related field OR 4+ years of direct Quality/Validation experience.



* 1+ year experience working in a regulated manufacturing environment, medical manufacturing preferred.

What Will Put You Ahead


* Experience with medical device regulatory environments, including FDA QSR and ISO 13485.



* Experience with GAMP5 Validation Principles for computerized systems.



* Competence with software: MS Office, SAP, Kneat Gx, MiniTab.



* Excellent communication skills and the ability to effectively work with cross-functional groups.



* Experienc...