We are seeking an experienced and hands-on Quality Manager to lead the Quality function at our growing medical device contract manufacturing site in Sturgeon Bay, WI.
In this role, you'll have the opportunity to make a meaningful impact within a growing and highly collaborative organization focused on quality, customer partnership, and operational excellence. Your leadership will directly influence site performance, team development, customer satisfaction, and long-term business success, and it will be critical to supporting operational excellence, developing talent, and enabling continued growth at the site.
What You'll Do- 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.
What You'll Bring- Bachelor's degree in Engineering, Quality, or a related technical discipline preferred.
- 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 and 211
- FDA 21 CFR Part 11
- Validation and qualification requirements within 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.
- Experience with statistical analysis, root cause investigation methodologies, and continuous improvement tools preferred.
- Ability to balance strategic leadership with hands-on execution in a fast-paced manufacturing environment.
At Cadence, quality is more than a function-it's foundational to everything we do. As Quality Manager, you'll have the opportunity to shape the future of our Sturgeon Bay, WI site, lead a talented team, and play a key role in delivering products that improve patient outcomes. If you're a collaborative leader who thrives in a hands-on environment and is passionate about building strong teams, driving continuous improvement, and making a meaningful impact, we'd love to hear from you.
