Quality Engineer

Phillips Medisize; Menomonie (WI); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Paid time off

Education assistance

Parental leave

Job summary

Phillips Medisize, a Molex Company, seeks a quality engineer to lead validation and quality assurance for NPI projects at our Menomonie, WI site. You will collaborate with project teams to define validation requirements, develop quality plans, and ensure compliance with FDA, GMP, and ISO 13485 standards.

The role involves drafting validation documentation, overseeing risk management, and supporting audits while traveling up to 50% to other Wisconsin sites.

Qualifications

• Lead validation and quality assurance activities for NPI projects.
• Define validation requirements and strategy with project teams.
• Develop and maintain quality plans for new medical device product introductions.
• Ensure compliance with regulatory requirements, including FDA and ISO standards.
• Draft and control validation documentation and validation reports.
• Travel to other Wisconsin Phillips Medisize sites up to 50%.

Responsibilities

• Lead validation and quality assurance activities for NPI projects.
• Define validation requirements and strategy with project teams.
• Develop and maintain quality plans for new medical device product introductions.
• Ensure regulatory compliance with FDA and ISO standards.
• Draft and control validation documentation (Master Validation Plans, protocols, deviations, reports).
• Manage quality/validation documentation, risk management, specifications, and work instructions.

Skills

Regulatory knowledge

Quality assurance

Cross-functional teamwork

Education

Bachelor’s degree in engineering, Quality, Life Sciences, or related field

Tools

MS Office

SAP

Kneat Gx

MiniTab

Job description

Phillips Medisize, a Molex Company, is seeking a contribution -motivatedQualityEngineerto join ourMenomonie, WI site.You will create value by stewarding New Product Introductions (NPI) with your background inMedical Device QualityAssuranceand Validationto ensure new projects/programsmeetcustomer, regulatory, and manufacturing requirements,a passion for ensuring the highest standards in product quality and compliance, and a commitment toexcellence.

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.
• Ensureprogramcompliance with regulatory requirements, including FDA (21 CFR 4, 11, 210, 211, 820),GMP, ISO 13485, etc.
• Draftandcontrolvalidation documentation, including Master Validation Plans, protocols, deviations, and summary reports.
• Manage and oversee quality/validationdocumentation, includingrisk 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 effortsto enhanceprogram validation, product quality, and manufacturing processes.
• Supportglobal Quality Systems and Validationrequirements through audits and inspectionsto ensure compliancewithinternal and external quality standards.
• Assist with documentation and audit readiness forregulatory body and customer audits.
• Travel to other Wisconsin Phillips Medisize sites (up to50%) with occasional travel outside Wisconsin as needed.
• Other duties as assigned

Who You Are (BasicQualifications)

• Bachelor’s degree inengineering, Quality, Life Sciences, or related fieldOR 4+ years of directQuality/Validation experience.
• 1+year experience working in a regulated manufacturing environment, medical manufacturing preferred.

What Will Put You Ahead

• Experience withmedical device regulatory environments,including FDAQSRandISO 13485.
• Experience with GAMP5Validation Principles for computerized systems.
• Competence withsoftware:MSOffice,SAP, Kneat Gx, MiniTab.
• Excellent communication skills and the ability to effectivelywork withcross-functional groups.
• Experience with product validation, verification, and risk management in medical devices.
• Strong organizationalandproblem-solving skillswith an understanding of the project development processand quality system requirements.

Hiring Philosophy

All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers.

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 ourbusiness philosophy helps employees unleash their potential while creating value for themselves and the company.

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.

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.

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.