Quality Manager (Medical Device Contract Manufacturing)

Cadence, Inc.; Cranberry Township (Butler County); Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

Cadence, Inc. in Cranberry Township, PA, is seeking an experienced Quality Manager to lead the Quality function at our growing finished medical device contract manufacturing site.

You will mentor the Quality team, ensure compliance with FDA regulations and ISO 13485, drive CAPA and internal audits, support customer audits, and collaborate with Manufacturing and Engineering to sustain operational excellence and patient-focused quality.

Qualifikationen

• Bachelor's degree in Engineering, Quality or related technical field.
• 5+ years of progressive quality leadership in regulated manufacturing (medical device/pharma preferred).
• Strong knowledge of FDA regulations and ISO 13485 compliance.
• Experience leading audits (customer, FDA, or notified body).

Aufgaben

• Lead, develop, and mentor the site Quality team.
• Ensure compliance with FDA regulations, ISO standards, and customer requirements.
• Maintain and improve the site's QMS including CAPA, NCRs, and audits.
• Oversee validation activities (IQ/OQ/PQ, process validation, equipment qualification).
• Prepare for customer audits and regulatory inspections; drive corrective actions.
• Collaborate with Manufacturing and Engineering to resolve quality issues.

Kenntnisse

Quality leadership

Cross-functional leadership

Problem solving

Statistical analysis

Root cause analysis

Continuous improvement

Regulatory knowledge

Ausbildung

Bachelor's in Engineering

Regulatory training

Jobbeschreibung

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Manager (Medical Device Contract Manufacturing)

Quality Indirect Full-Time Employee - 40 hr/week - 8 Hour Shift M3 Cranberry Township, PA, US

We are seeking an experienced and hands-on Quality Manager to lead the Quality function at our growing finished medical device contract manufacturing site in Cranberry Twp. PA.

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, FDA inspections, 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.

Why Join Us?
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 Cranberry Twp. 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.