What are the responsibilities and job description for the Quality Manager – Medical Device Manufacturing position at Sterling Engineering?
Quality Manager – Medical Device Manufacturing
Location: Libertyville, IL
Salary Range: $140,000 – $155,000/year Bonus
Brief Overview:
Reporting to senior site leadership, the Quality Manager will lead the Quality function across both new product introduction (NPI) and sustaining manufacturing. This role will oversee a team of both quality engineers and quality technicians while driving compliance, continuous improvement, and remediation efforts within a regulated medical device environment.
A key priority for this role is leading and supporting RDA (Remediation) initiatives, ensuring quality systems, documentation, and processes meet regulatory requirements and industry standards.
What a typical day looks like:
- Provide leadership and direction to the site Quality team, including Quality Engineers and Inspectors
- Own and drive site-level Quality Management System (QMS) compliance (21 CFR 820, ISO 13485, ISO 14971)
- Lead and execute RDA / remediation activities, including gap assessments, documentation updates, and audit readiness
- Oversee product and process quality for both new product introduction and sustaining manufacturing
- Drive CAPA, nonconformance investigations, and customer complaint resolution to effective closure
- Ensure robust risk management practices (PFMEA, hazard analysis) are implemented and maintained
- Guide development and execution of inspection plans, control plans, and process validation activities
- Leverage statistical methods (SPC, DOE) to support data-driven decision making and process improvements
- Partner cross-functionally with Operations, Engineering, and Regulatory to resolve quality issues and improve processes
- Lead internal and external audits, including FDA and notified body inspections
- Drive continuous improvement initiatives using Lean and Six Sigma methodologies
- Establish and track key quality metrics, ensuring visibility and accountability across the organization
- Mentor and develop team members while fostering a culture of quality and compliance
The experience we’re looking to add to our team:
- Bachelor’s degree in Engineering or related technical field
- 8 years of experience in Quality within a regulated manufacturing environment
- 3 years of leadership or people management experience
- Strong background in medical device manufacturing (21 CFR 820, ISO 13485, ISO 14971 required)
- Direct experience leading or supporting RDA / remediation efforts (highly preferred / critical)
- Experience with molding manufacturing processes (preferred)
- Strong experience with CAPA, risk management, and audit support
- Working knowledge of statistical tools (SPC, DOE)
- ASQ Certification (CQE, CQM, or similar) preferred
Salary : $140,000 - $155,000