Senior Quality Leader – Medical Device Manufacturing

Cadence, Inc.; Sturgeon Bay (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Cadence, Inc. in Sturgeon Bay, WI, seeks an experienced Quality Manager to lead the site quality function at our medical device contract manufacturing facility.

You will mentor the Quality Engineers, Technicians, and Inspectors, and partner with Manufacturing and Engineering to ensure robust processes and patient safety. The role requires deep knowledge of FDA regulations and ISO 13485, plus experience with CAPA, audits, validation, and continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Quality, or a related technical discipline.
• Five or more years of progressive Quality leadership experience in a regulated manufacturing environment; medical device and/or pharmaceutical manufacturing experience is strongly preferred.
• Strong working knowledge of FDA regulations and quality standards, including ISO 13485, FDA 21 CFR Part 210/211, and FDA 21 CFR Part 11.
• Experience leading quality teams within a manufacturing operation of significant scale and complexity.
• Demonstrated success supporting customer audits and/or notified body audits.
• Strong problem-solving, communication, and cross-functional leadership skills.
• Experience with statistical analysis, root cause investigation methodologies, and continuous improvement tools.

Responsibilities

• Lead, develop, and mentor the site Quality team, including Quality Engineers, Technicians, Metrology personnel, Supervisory staff, and Quality Inspectors.
• Ensure compliance with applicable FDA regulations, ISO standards, customer requirements, and internal quality management systems.
• Maintain and continuously improve the site's Quality Management System (QMS), including CAPA, nonconformance management, complaint handling, document control, change management, and internal audits.
• Provide leadership and oversight for validation activities, including IQ/OQ/PQ, process validation, equipment qualification, and computerized system validation.
• Prepare for and support customer audits, regulatory inspections, and third-party audits, including coordinating responses and driving corrective actions to closure.
• Partner with Manufacturing and Engineering teams to investigate quality issues, perform root cause analysis, mitigate risks, and implement sustainable improvements.
• Monitor and analyze quality metrics to identify trends, address risks, and drive performance improvements.
• Ensure inspection and metrology systems are capable, compliant, and effective in supporting manufacturing and customer requirements.
• Foster a culture of quality, accountability, continuous improvement, and operational excellence throughout the facility.
• Coach and develop team members to strengthen technical expertise, leadership capabilities, and overall organizational effectiveness.

Skills

Quality leadership

FDA regulations knowledge

ISO 13485

Quality systems

Root cause analysis

Cross-functional leadership

Education

Bachelor's degree in Engineering / Quality

Job description

Cadence, Inc. in Sturgeon Bay, WI, seeks an experienced Quality Manager to lead the site quality function at our medical device contract manufacturing facility.

You will mentor the Quality Engineers, Technicians, and Inspectors, and partner with Manufacturing and Engineering to ensure robust processes and patient safety. The role requires deep knowledge of FDA regulations and ISO 13485, plus experience with CAPA, audits, validation, and continuous improvement.