What are the responsibilities and job description for the Quality Engineer position at Phillips Medisize?
Your Job
Phillips Medisize, a Molex Company, is seeking a Quality Engineer to join our team in Menomonie, Wisconsin.
This role will support, organize, and coordinate activities of the quality function with the goal of providing products/services that meet customer expectations. Devise and implement continuous improvement methodology supporting manufacturing, support groups and ensure customer satisfaction is maintained.
Our Team
Phillips Medisize, LLC, a Molex company, is a leading global provider of medical molding and assembly services.
What You Will Do
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
As a Molex company, Phillips Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.
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.
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 visit the following website for additional information: http://www.kochcareers.com/doc/Everify.pdf
Phillips Medisize, a Molex Company, is seeking a Quality Engineer to join our team in Menomonie, Wisconsin.
This role will support, organize, and coordinate activities of the quality function with the goal of providing products/services that meet customer expectations. Devise and implement continuous improvement methodology supporting manufacturing, support groups and ensure customer satisfaction is maintained.
Our Team
Phillips Medisize, LLC, a Molex company, is a leading global provider of medical molding and assembly services.
What You Will Do
- Ensure compliance with FDA 21 CFR 820 210:211, ISO 13485, and ISO 14971.
- Review specifications and ensure adherence to material and process requirements.
- Oversee validation and verification of manufacturing processes and equipment.
- Manage documentation for change management and non-conformance reports.
- Lead investigations and root cause analysis of non-conformances.
- Author tech reports, CAPAs, compliant investigations, and validations.
- Work with suppliers to meet quality requirements.
- Support customer complaint management.
- Troubleshoot manufacturing and field issues.
- Analyze quality data and trends; identify improvement areas.
- Champion continuous improvement initiatives.
- Collaborate with cross-functional teams.
- Bachelor's degree or equivalent experience
- Minimum of 2 years of quality-related experience in a medical manufacturing environment
- Working knowledge of regulatory requirements including FDA 21 CFR 820, ISO 13485
- Strong technical writing and problem-solving skills in CAPA documentation and change management documentation
- Experience in packaging, serialization, sterilization, and complaint handling
- Experience in supplier quality management
- Pharmaceutical experience
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
As a Molex company, Phillips Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.
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.
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 visit the following website for additional information: http://www.kochcareers.com/doc/Everify.pdf