Quality Engineer

Overview

Quality Engineer at Phillips Medisize, a Molex Company, New Richmond, Wisconsin. You will create value by stewarding New Product Introductions (NPI) with a background in Medical Device Quality Assurance and a commitment to excellence.

• Lead quality assurance activities for new product introduction (NPI) projects to ensure compliance with regulatory requirements (FDA, GMP, ISO 13485, etc.).
• Develop and maintain quality plans for new medical device product introductions.
• Perform audits and inspections of NPI processes to ensure adherence to internal and external quality standards.
• Manage and oversee quality documentation, including specifications, validation reports, and product dossiers.
• Support regulatory submissions by compiling and reviewing quality-related documentation.
• Monitor product performance during initial production runs to identify opportunities for improvement.
• Facilitate training and knowledge sharing across teams regarding quality expectations and best practices.
• Stay informed of industry trends and regulatory updates to ensure compliance and competitiveness.
• Lead risk management activities including Design FMEA, Process FMEA, and Control Plans.
• Collaborate with suppliers on quality requirements and audits to ensure component and material quality.
• Facilitate root cause investigations and corrective actions for quality issues during product launch.
• Conduct quality reviews and ensure alignment with internal standards and external regulatory bodies.
• Assist with documentation and audit readiness for FDA inspections and ISO 13485 certification.
• Drive continuous improvement efforts to enhance product quality and manufacturing processes.

• Bachelor’s degree in engineering, Quality, Life Sciences, or related field.
• Experience with FDA QSR, ISO 13485, and medical device regulatory environment.
• Strong knowledge of quality tools such as SPC, FMEA, 8D, CAPA.
• Excellent problem-solving skills and ability to work cross-functionally.
• Experience with product validation, verification, and risk management in medical devices.
• Legal authorization to work permanently in the United States for any employer without requiring a visa transfer or visa sponsorship.

Note:

This role is not eligible for VISA sponsorship. 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. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. 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. Molex is a multi-sector global electronics brand owned by Koch, Inc.,

one of the world’s largest privately held companies.

Our benefits plan includes medical, dental, vision, flexible spending and health savings accounts, life insurance, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Eligibility criteria are set by the applicable Summary Plan Description and benefits may vary by geographic region. Please speak to your recruiter for details.

Equal Opportunity Employer, including disability and protected veteran status. Some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please  for additional information.