Quality Engineer - Regulatory & Continuous Improvement

Phillips Medisize; Hudson (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Phillips-Medisize in Hudson, WI is seeking a Quality Engineer to lead and coordinate the quality function within our North America R&D facility. You will ensure product and process quality meets customer expectations and regulatory requirements.

You will drive CAPAs, change controls, supplier quality, and validation activities while mentoring junior engineers and partnering across Engineering, Operations, Regulatory, and Quality teams to deliver robust, compliant products.

Qualifications

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

Responsibilities

• 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.
• 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.

Skills

Quality systems

Risk management

Continuous improvement

Root cause analysis (CAPA)

Technical drawing interpretation

Analytical thinking

Data-driven decision making

Communication & collaboration

Statistical analysis tools (SPC/Minitb

Data analysis

Education

Bachelor's degree in engineering

Tools

SAP

Job description

Phillips-Medisize in Hudson, WI is seeking a Quality Engineer to lead and coordinate the quality function within our North America R&D facility. You will ensure product and process quality meets customer expectations and regulatory requirements.

You will drive CAPAs, change controls, supplier quality, and validation activities while mentoring junior engineers and partnering across Engineering, Operations, Regulatory, and Quality teams to deliver robust, compliant products.