Quality Control Manager

About Cretex Medical

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in injection molding, laser processing, metal stamping, and device assembly. Learn more at

The Quality Control Manager (QC Operations) leads Incoming Inspection, In-Process Inspection, Final Inspection, and Quality Laboratory functions while partnering closely with New Product Development (NPD/NPI) and Manufacturing to ensure compliant product realization and operational excellence. This role drives risk-based quality control strategies, regulatory compliance, and continuous improvement to deliver high-quality products right the first time. The role requires a hands‑on technical leader who can set direction, prioritize workload, coach and develop the team, and effectively interface with plant leadership and cross‑functional stakeholders.

• Lead, coach, and develop Inspection and Quality Control teams across Incoming, In-Process, and Final Inspection, as well as Quality Laboratory functions.
• Establish and manage Inspection & QC objectives and KPIs aligned with site quality, safety, delivery, and cost targets.
• Build a high‑performance culture focused on compliance, defect prevention, continuous improvement, and accountability.
• Drive workforce planning and resource allocation to support production demand, new product introductions (NPI), and engineering changes.
• Ensure inspector training, certification, and qualification meet regulatory and technical requirements.

• Own the end‑to‑end inspection and quality control lifecycle, from requirements definition through validation, release, and controlled change for production use.
• Establish and maintain standardized work for inspection methods, sampling plans, documentation, and change control within the Quality Management System.
• Ensure inspection processes are robust, efficient, and capable, delivering accurate, repeatable, and reliable results.
• Define and govern inspection strategies, including visual, dimensional, functional, and test methods, aligned with engineering requirements and risk‑based quality principles.
• Drive standardization of inspection approaches across parts, processes, shifts, and sites to reduce variation, rework, and release cycle time.

• Lead initiatives to improve first‑time‑right quality, reduce cycle time inspection, and lower the cost of poor quality.
• Ensure adherence to regulatory requirements, internal procedures, and customer standards for inspection and product release.
• Maintain compliant documentation, including inspection records, DHRs, validation evidence, and controlled procedures.
• Incorporate lessons learned from nonconformances, escapes, and audits into updated inspection methods and controls.
• Apply data‑driven tools such as SPC, trend analysis, and risk‑based sampling to drive proactive quality improvement.

• Partner with Design, Operations, Engineering, and Quality to align inspection strategy with manufacturing execution.
• Communicate performance trends, risks, and improvement actions clearly to site leadership.
• Support NPI readiness and engineering changes through inspection planning and execution.
• Represent Inspection & Quality Control in cross‑functional reviews and audits.

• Bachelor’s degree in engineering, or related field.
• 5+ years in Quality Control or Manufacturing Quality.
• Strong FDA 21 CFR 820 and ISO 13485 knowledge.
• 5+ years of Leadership experience.

• Lean/Six Sigma experience.
• High‑mix manufacturing environment experience.
• Strong data and problem‑solving skills.

Cretex Medical offers a competitive salary, a rich benefits package, and a focus on continuous improvement. Benefits include a 401(k) plan with company match, onsite health clinics, a discretionary holiday bonus, employee assistance program, wellness programs, life insurance, sick & safe leave, and more.…