$140,000–$155,000 Per Year
Quality Manager – Medical Device Manufacturing
Location: Buffalo Grove, IL
Salary Range: $140,000 – $155,000 base
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 quality engineers and technicians, while driving compliance, continuous improvement, and regulatory readiness within a medical device environment.
A key priority for this role is leading and supporting FDA remediation initiatives, ensuring quality systems, documentation, and processes are aligned with regulatory expectations and audit requirements.
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 FDA remediation activities, including gap assessments, remediation plans, and audit readiness
- Partner with Regulatory and site leadership to address FDA observations, warning letters, or audit findings
- 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, hands-on experience with FDA remediation efforts (e.g., audit findings, 483 responses, warning letters) — required
- Proven success leading remediation plans through closure and sustaining compliance
- 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
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Sterling Engineering, Inc.
Sterling Engineering has been a trusted partner for engineering, project management, and staffing solutions for over five decades. We provide exceptional engineering/technical recruitment and engineering project services to clients nationwide:
- Engineering & Technical Recruitment - With our focus on engineering, technical, and IT, Sterling has the in-depth knowledge, industry expertise, and robust employee pipeline it takes to rapidly find talent for even the most difficult to fill positions. Sterling’s extensive recruitment methodology allows us to engage the most talented employees in the marketplace. We offer exciting work and career-building opportunities for our candidates, along with expert support at every step of the process.
- Engineering Project Services – Our experienced, multi-disciplined team of project managers, engineers, and designers, led by licensed Professional Engineers (PE), provide project management, engineering, design, and Commissioning, Qualification, and Validation (CQV) to manufacturing, OEM, and R&D customers. We work on complex, highly technical projects across a number of industry sectors, and our ability to scale and seamlessly integrate at multiple levels of your organization is what differentiates us.
Sterling offers a unique combination of engineering solutions and Best of Staffing level service to help our clients and talent achieve their goals.
500 to 999 employees
Staffing/Employment Agencies
http://www.sterling-engineering.com