Quality Manager (Medical Device Contract Manufacturing)

Cadence, Inc.•Sturgeon Bay, WI

3d•Onsite

About The Position

Cadence is seeking an experienced, hands-on Quality Manager to lead the Quality function at its growing medical device contract manufacturing site in Sturgeon Bay, Wisconsin. The role provides leadership over site performance, team development, customer satisfaction, operational excellence, and continued business growth. The Quality Manager will lead a multidisciplinary Quality team and help ensure that quality systems and manufacturing processes meet regulatory, customer, and internal requirements.

Requirements

Five or more years of progressive Quality leadership experience in a regulated manufacturing environment.
Strong working knowledge of FDA regulations and quality standards, including ISO 13485, FDA 21 CFR Parts 210 and 211, FDA 21 CFR Part 11, and validation and qualification requirements in regulated manufacturing environments.
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.
Ability to balance strategic leadership with hands-on execution in a fast-paced manufacturing environment.

Nice To Haves

Bachelor's degree in Engineering, Quality, or a related technical discipline is preferred.
Medical device and/or pharmaceutical manufacturing experience is strongly preferred.
Experience with statistical analysis, root cause investigation methodologies, and continuous improvement tools is preferred.

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, including CAPA, nonconformance management, complaint handling, document control, change management, and internal audits.
Lead and oversee 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; coordinate responses and drive corrective actions to closure.
Partner with Manufacturing and Engineering teams to investigate quality issues, conduct 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.
Promote 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 organizational effectiveness.