Senior QA Engineer - Medical Devices (Onsite + Relocation)

Cadence Inc.; Sturgeon Bay (WI); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Relocation package offered

Job summary

Cadence Inc. is seeking a Quality Assurance Engineer II to ensure products meet strict quality standards in a fast-paced medical device manufacturing environment.

You will support QMS, audits, CAPA, and process validation while collaborating with manufacturing, engineering, and regulatory teams. The role emphasizes root cause analysis, risk management, and continuous improvement to ensure safety and efficacy of devices produced at the Sturgeon Bay site.

Qualifications

• Reading mechanical drawings and using precision measurement instruments.
• Strong knowledge of Geometric Dimensioning and Tolerancing (GD&T).
• Bachelor's degree in Engineering or related field or equivalent experience.
• 5–10 years of experience in quality engineering within the medical device industry.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and related standards.
• Experience with risk management methods (FMEA) and statistical analysis techniques.
• Proficiency in CAPA, root cause analysis, process validation, and quality tools.
• Excellent communication, problem-solving, and teamwork skills.
• Willingness to work primarily onsite; relocation package offered.

Responsibilities

• Maintain Quality Management System (QMS) compliance with ISO 13485, FDA 21 CFR Part 820, and other standards.
• Coordinate internal and external audits, including supplier audits and regulatory inspections.
• Lead CAPA to address non-conformances and ensure timely closure of quality events.
• Support continuous improvement projects to reduce defects and improve product quality.
• Lead and prepare validation protocols and reports; coordinate validation activities across departments.
• Program CMM software and create measurement routines from engineering drawings.
• Qualify and manage suppliers to ensure materials meet specifications.
• Prepare technical documentation and SOPs; maintain records for traceability.
• Provide quality training to staff on cleanroom operations and regulatory requirements.

Skills

Reading drawings

Precision measurement

GD&T

Quality engineering

Regulatory compliance

FMEA

CAPA

Process validation

Statistical analysis

Root cause analysis

Communication

Education

Bachelor's degree in Engineering or related field

Job description

Cadence Inc. is seeking a Quality Assurance Engineer II to ensure products meet strict quality standards in a fast-paced medical device manufacturing environment.

You will support QMS, audits, CAPA, and process validation while collaborating with manufacturing, engineering, and regulatory teams. The role emphasizes root cause analysis, risk management, and continuous improvement to ensure safety and efficacy of devices produced at the Sturgeon Bay site.