Quality Engineer

Koch Business Solutions, LP; Menomonie (WI); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Paid vacation

Job summary

A leading global provider of medical services in Menomonie, Wisconsin is seeking a Quality Engineer to ensure compliance with regulatory standards and enhance quality processes. The ideal candidate will have a Bachelor's degree or Associates Degree and at least 2 years of quality-related experience. Responsibilities include managing documentation, leading investigations, and championing continuous improvement initiatives. The position offers comprehensive benefits focused on employee wellbeing.

Qualifications

• Bachelor's degree or Associates Degree with 2+ years of experience.
• Minimum of 2 years of quality-related experience required.
• Working knowledge of regulatory requirements including FDA 21 CFR 820, ISO 13485.

Responsibilities

• Ensure compliance with FDA and ISO standards.
• Review specifications and ensure adherence to requirements.
• Oversee validation and verification of processes.

Skills

Regulatory compliance

Technical writing

Problem-solving

Education

Bachelor's degree

Associates Degree

Job description

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

• 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.

Who You Are (Basic Qualifications)

• Bachelor's degree or Associates Degree with 2+ years of experience
• Minimum of 2 years of quality-related experience
• Working knowledge of regulatory requirements including FDA 21 CFR 820, ISO 13485
• Strong technical writing and problem-solving skills

What Will Put You Ahead

• Experience in supplier quality management
• Pharmaceutical experience

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 click here for additional information. (For Illinois E-Verify information click here, aqui, or tu).