Quality Engineer, Medical Devices & Compliance

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

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.