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 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. Responsibilities 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, 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. 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. Qualifications 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. Benefits 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. Employees working 20+ hours per week are eligible for a comprehensive medical, dental, vision, HSA, and additional benefits. Those working 30+ hours per week receive additional benefits such as parental leave, accident & critical illness coverage, optional life insurance, and tuition assistance. Pay Range USD $100,900.00 – USD $151,300.00 per year. Equal Employment Opportunity Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E‑Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E‑Verify, including your rights and responsibilities, please visit #J-18808-Ljbffr