Phillips Medisize
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Quality Engineer
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Koch 2 days ago Be among the first 25 applicants Join to apply for the
Quality Engineer
role at
Koch Get AI-powered advice on this job and more exclusive features. Your Job
Phillips-Medisize, a Molex Company, is seeking a Quality Engineer to join our teams in Wisconsin.
We have opportunities available at our Your Job
Phillips-Medisize, a Molex Company, is seeking a Quality Engineer to join our teams in Wisconsin.
We have opportunities available at our
New Richmond, Menomonie, and Hudson
facilities.
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. Mentor junior quality engineers. Collaborate with cross-functional teams.
Who You Are (Basic Qualifications):
Bachelor's degree or equivalent experience Minimum of 4 years of quality-related experience in a medical manufacturing environment Experience working in a regulated environment Knowledge of automated assembly and test procedures Working knowledge of regulatory requirements including FDA 21 CFR 820, ISO 13485 Experience working with an ERP system (SAP) Strong data analysis skills Strong technical writing and problem-solving skills Experience in packaging, serialization, sterilization, and complaint handling Experience with updating the test procedures in testing equipment
What Will Put You Ahead:
Experience in supplier quality management Pharmaceutical experience
LI-SD5
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 Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Referrals increase your chances of interviewing at Koch by 2x Sign in to set job alerts for “Quality Engineer” roles.
Civil Engineer Advanced - PDS Quality Assurance Engineer
Civil Engineer Senior or Advanced - Construction QA Engineer
Civil Engineer Advanced (Project Manager) - Open Statewide!
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Licensed Architect or Professional Engineer
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Quality Engineer
role at
Koch 2 days ago Be among the first 25 applicants Join to apply for the
Quality Engineer
role at
Koch Get AI-powered advice on this job and more exclusive features. Your Job
Phillips-Medisize, a Molex Company, is seeking a Quality Engineer to join our teams in Wisconsin.
We have opportunities available at our Your Job
Phillips-Medisize, a Molex Company, is seeking a Quality Engineer to join our teams in Wisconsin.
We have opportunities available at our
New Richmond, Menomonie, and Hudson
facilities.
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. Mentor junior quality engineers. Collaborate with cross-functional teams.
Who You Are (Basic Qualifications):
Bachelor's degree or equivalent experience Minimum of 4 years of quality-related experience in a medical manufacturing environment Experience working in a regulated environment Knowledge of automated assembly and test procedures Working knowledge of regulatory requirements including FDA 21 CFR 820, ISO 13485 Experience working with an ERP system (SAP) Strong data analysis skills Strong technical writing and problem-solving skills Experience in packaging, serialization, sterilization, and complaint handling Experience with updating the test procedures in testing equipment
What Will Put You Ahead:
Experience in supplier quality management Pharmaceutical experience
LI-SD5
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 Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Referrals increase your chances of interviewing at Koch by 2x Sign in to set job alerts for “Quality Engineer” roles.
Civil Engineer Advanced - PDS Quality Assurance Engineer
Civil Engineer Senior or Advanced - Construction QA Engineer
Civil Engineer Advanced (Project Manager) - Open Statewide!
Civil Engineer Advanced - Local Program Project Manager
Civil Engineering Project Manager - Land Development
Civil Engineering Manager - Land Development
Civil Engineer Advanced - Project Manager
Licensed Architect or Professional Engineer
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr