Quality Engineer

Your Job

Our Team

What You Will Do

• 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
• Work with project teams and Validation leads to define the validation strategy
• Draft MVPs, equipment qualification, protocol/test case, deviations and summary report documentation for project wrap up
• 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 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

Who You Are (Basic Qualifications)

• 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 (ex. SPC, FMEA, 8D, or 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

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. 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, aqui, or tu).

#LI-CK1