Quality Control Manager

Cretex Medical Component and Device Technologies; Brooklyn Park (MN); Sur place; USD 100 900 - 151 300; Plein temps

Avantages offerts par ce poste

Bonus eligible

401k retirement savings plan

Comprehensive medical insurance

Wellness program with incentives

Tuition assistance programs

Résumé du poste

Cretex Medical Component and Device Technologies is seeking a Quality Control Manager to lead inspection and quality control functions. This role involves partnering with teams to ensure compliant product realization and drive operational excellence. Responsibilities include team leadership, quality strategy development, and stakeholder communication. Requires a Bachelor's degree in engineering, 5+ years in Quality Control, and strong knowledge of FDA and ISO standards. Competitive salary range of USD $100,900.00 - USD $151,300.00/year.

Qualifications

• 5+ years in Quality Control or Manufacturing Quality.
• 5+ years of Leadership experience.
• Experience in high-mix manufacturing environment.

Responsabilités

• Lead, coach, and develop Inspection and Quality Control teams.
• Own the end-to-end inspection and quality control lifecycle.
• Drive initiatives to improve first-time-right quality and reduce cycle time inspection.
• Partner with cross-functional teams to align inspection strategy.

Connaissances

Strong FDA 21 CFR 820 knowledge

ISO 13485 knowledge

Lean/Six Sigma experience

Strong data and problem-solving skills

Formation

Bachelor’s degree in engineering or related field

Description du poste

Overview

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.

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, & 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.

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

Pay Range

USD $100,900.00 - USD $151,300.00 /Yr.

Pay Range Details

This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market‑based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range.

Company Benefits

Compensation:

This is a bonus eligible position.

All Employees:

Our 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, an employee death benefit, and employee sick and safe leave are available to all Cretex employees.

20+ hours:

Cretex’s medical benefit package includes 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; a pre‑tax health savings account, healthcare and dependent care pre‑tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week.

30+ hours:

Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week.

(Some benefits are subject to eligibility criteria.)

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 www.dhs.gov/E-Verify.