Cretex Medical Component and Device Technologies · 14 hours ago
Quality Control Manager
Minneapolis, MN
Full-time
Onsite
Senior Level
5+ years expCretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. The Quality Control Manager leads inspection and quality control functions while partnering with New Product Development and Manufacturing to ensure compliant product realization and operational excellence.
Medical Device
No H1B
Responsibilities
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, & 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
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
Qualification
Required
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
Preferred
Lean/Six Sigma experience
High-mix manufacturing environment experience
Strong data and problem-solving skills
Benefits
401k retirement savings plan with a company match contribution
Onsite health clinics
Discretionary holiday bonus program (based on years of service)
Cretex University
24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost
Wellness program with incentives
Employee death benefit
Employee sick and safe leave
Comprehensive medical insurance with access to virtual providers
Dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider)
Vision insurance
Pre-tax health savings account
Healthcare and dependent care pre-tax reimbursement accounts
Paid holidays
Paid time off
Discretionary profit sharing program
Parental Leave
Accident and critical illness benefits
Optional employee, spouse, and child life
Short and long term disability
Company provided life insurance
Tuition assistance programs
Company
Cretex Medical Component and Device Technologies
Our mission is to make it easier for our customers to get their products to the patients who need them.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase