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.
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.
- Experience with product validation, verification, and risk management in medical devices.
- Strong organizational and problem-solving skills with an understanding of the project development process and quality system requirements.
At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.
Hiring Philosophy
All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy here .
Who We Are
Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers' mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc., one of the world's largest privately held companies. Discover your potential to make a difference.
At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.
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.
Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.
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. (For Illinois E-Verify information click here , aquí , or tu ).
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