Quality Engineer

Koch Business Solutions, LP; Hudson (WI); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Retirement

Paid vacation/time off

Educational assistance

Infertility assistance

Paid parental leave

Adoption assistance

Job summary

Phillips-Medisize, a Molex company, is seeking a Quality Engineer to join our Hudson, Wisconsin Research and Development facility. You will lead quality activities to ensure products meet customer and regulatory requirements.

Responsibilities include ensuring FDA/ISO compliance, leading validation activities, coordinating CAPAs, and partnering with suppliers and internal teams to drive continuous improvement.

Qualifications

• Bachelor's degree in engineering or related field.
• 5+ years quality/regulatory experience.
• Experience with ERP systems; SAP preferred.
• Data analysis experience.

Responsibilities

• Ensure compliance with FDA 21 CFR 820, 21 CFR 210/211, ISO 13485, ISO 14971.
• Lead validation and verification activities for processes and systems.
• Review specs, materials, and processes for quality and regulatory compliance.
• Manage quality system documentation: CAPAs, change controls, NCRs.
• Investigate issues, perform root cause analysis, implement corrective actions.
• Collaborate with suppliers and internal stakeholders to improve quality.
• Support customer complaint investigations and resolve issues.
• Analyze quality metrics to identify risks and reduce recurring issues.
• Champion continuous improvement in quality and operations.
• Collaborate across Engineering, Operations, Regulatory, and Quality; mentor juniors.

Skills

Quality management

Data analysis

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

SAP

Job description

Your Job

Phillips-Medisize, a Molex company is seeking a Quality Engineer to join our team in Hudson, Wisconsin at our Research and Development - North America facility.

This role will lead, 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

At Phillips Medisize, our goal is to create value for others. We empower every team member to hear, feel and see the quality in every action we take. By incorporating quality into the design of products and processes and predicting potential quality problems before manufacturing and delivering the product, we can create mutual benefit. The leading task of quality control involves enforcing the use of specified processes and materials, ensuring the qualification of operators and equipment, and making a series of planned measurements to determine if quality standards are being met.

What You Will Do

• Ensure compliance with FDA 21 CFR 820, 21 CFR 210/211, ISO 13485, ISO 14971, and other applicable quality system requirements.
• Lead validation and verification activities for manufacturing processes, equipment, and quality systems.
• Review product specifications, materials, and manufacturing processes to ensure quality, safety, and regulatory compliance.
• Manage quality system documentation, including change controls, nonconformance reports, investigations, CAPAs, and validation records.
• Investigate quality issues, perform root cause analysis, and implement corrective and preventive actions to drive sustainable solutions.
• Partner with suppliers and internal stakeholders to ensure quality requirements are met and continuously improved.
• Support customer complaint investigations and provide technical expertise to resolve manufacturing and field quality issues.
• Analyze quality metrics and trends to identify risks, improve performance, and reduce recurring issues.
• Champion continuous improvement initiatives that enhance product quality, compliance, and operational effectiveness.
• Collaborate across Engineering, Operations, Regulatory, and Quality teams while mentoring and supporting the development of junior engineers.

Who You Are (Basic Qualifications)

• Bachelor's degree in an Engineering related field
• 5+ years Quality/Regulatory experience
• Experience with an ERP system, SAP preferred
• Data analysis experience

What Will Put You Ahead

• Strong understanding of quality systems, risk management, and continuous improvement methodologies.
• Ability to investigate nonconformances, identify root causes (CAPA), and implement effective corrective actions.
• Experience interpreting technical drawings, specifications, and regulatory or customer requirements.
• Excellent analytical, problem-solving, and data-driven decision-making skills.
• Strong communication and collaboration skills with the ability to work effectively across cross-functional teams.
• Proficiency in statistical analysis and quality improvement tools such as SPC, Minitab, and FMEA.
• Strong interpersonal skills with the ability to influence and collaborate across engineering, operations, and quality teams.

This position does not qualify for VISA Sponsorship.

In order to comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and/or the Export Administration

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.

• medical
• dental
• vision
• flexible spending and health savings accounts
• life insurance
• ADD
• disability
• retirement
• paid vacation/time off
• educational assistance
• infertility assistance
• paid parental leave
• 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. (For Illinois E-Verify information, aqui, or tu).