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 the areas of injection molding, laser processing, metal stamping and device assembly.  Learn more at www.cretexmedical.com.

Quality Control Manager Position Summary:

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.

Leadership & Team Management

• 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.

Measurement Process Ownership

• 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.

Continuous Improvement & Compliance

• 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, & customer standards for inspection & 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.

Stakeholder Management & Communication

• 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.

Quality Control Manager Requirements: 

• 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

Quality Control Manager Preferred Requirements: 

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