Quality Engineering Manager

Overview

About Cretex Medical

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our capabilities include injection molding, laser processing, metal stamping, and device assembly. We partner with leading medical device manufacturers to deliver innovative, high-quality products that improve patients’ lives.

Position Summary

Cretex Medical is seeking a hands-on, results-oriented Quality Engineering Manager to lead inspection operations, measurement systems and quality laboratory functions while advancing engineering-driven quality improvements across new product introduction and manufacturing operations.

This leader will be responsible for developing and implementing robust, risk-based inspection and measurement strategies, improving operational efficiency, preventing defects, and ensuring products consistently meet customer and regulatory requirements.

The successful candidate will combine strong technical expertise with practical manufacturing knowledge, effective people's leadership, and a continuous improvement mindset. The role requires close collaboration with Manufacturing, Engineering, New Product Introduction (NPI), and Quality teams to strengthen process capability, improve first-time-right performance, and drive sustainable quality improvements.

Responsibilities

Quality Leadership & Team Development

• Lead, coach and develop teams responsible for new product introduction, Incoming, In-Process and Final Inspection and Quality Laboratory operations.
• Build technical capabilities in quality engineering principles, measurement science, problem-solving and continuous improvement.
• Establish clear performance expectations, priorities and accountability through measurable quality, delivery and operational KPIs.
• Optimize resource planning, workload management and team capabilities to support manufacturing and NPI demands.
• Foster a culture of collaboration, technical excellence, proactive problem-solving and defect prevention.

Quality Engineering & Measurement Systems

• Develop and implement robust, risk-based inspection and measurement strategies aligned with product requirements, process capabilities and customer expectations.
• Lead improvements in inspection methods, measurement system capability, sampling strategies and inspection process validation or qualification, as applicable.
• Apply engineering tools including Measurement System Analysis (MSA), Gage R&R, Statistical Process Control (SPC), GD&T and statistical analysis to strengthen measurement reliability and product quality.
• Drive standardization and optimization of inspection methods across products, manufacturing processes and shifts.
• Leverage automated inspection technologies, metrology systems and digital quality data to improve accuracy, efficiency and consistency.
• Partner with appropriate teams to ensure measurement equipment selection, qualification, calibration and maintenance support reliable results.

Manufacturing Quality & Continuous Improvement

• Drive engineering-led improvements that reduce inspection cycle time, rework, defects and cost of poor quality.
• Partner with Manufacturing and Quality Engineering to analyze process performance, identify sources of variation and implement sustainable improvements.
• Support structured root-cause investigations and corrective actions related to manufacturing nonconformances, inspection failures and product quality issues.
• Apply risk-based approaches and data analysis to optimize inspection effectiveness while maintaining regulatory and customer requirements.
• Champion continuous improvement initiatives that shift quality activities from defect detection toward defect prevention.

New Product Introduction & Manufacturing Readiness

• Collaborate with NPI, Manufacturing Engineering and Quality Engineering to develop inspection strategies and measurement methods for new products.
• Support manufacturing readiness through inspection planning, measurement capability assessments and inspection method qualification.
• Provide technical input into PFMEA, control plans, process validations and engineering changes within the role’s area of responsibility.
• Ensure effective transfer of inspection methods, technical knowledge and quality controls from development into routine production.

Quality Systems, Compliance & Business Partnership

• Ensure inspection activities, measurement processes and associated quality records comply with applicable FDA QMSR, ISO 13485, internal quality system and customer requirements.
• Maintain effective controls for inspection of documentation, measurement methods, process changes and records supporting product release.
• Support internal, customer and regulatory audits, and address relevant findings through sustainable improvements.
• Partner with Quality Systems, Supplier Quality, Manufacturing and NPI teams to improve end-to-end quality performance.
• Communicate key quality performance trends, risks, improvement opportunities and action plans to site leadership.

Qualifications

Required Qualifications

• Bachelor's degree in engineering or related technical discipline.
• 5+ years of experience in Quality Engineering, Manufacturing Quality, Inspection Engineering or Metrology within a regulated or precision manufacturing environment.
• Demonstrated experience leading, coaching and developing technical or operational teams.
• Strong understanding of inspection methods, measurement systems, GD&T, quality engineering principles and structured problem-solving.
• Working knowledge of ISO 13485 and applicable FDA Quality Management System Regulation (21 CFR Part 820) requirements.
• Ability to apply data-driven approaches to quality improvement, problem-solving and operational decision-making.
• Strong cross-functional communication, prioritization and execution skills.

Preferred Qualifications

• Medical device manufacturing or contract manufacturing experience.
• Experience with precision manufacturing processes such as injection molding, laser processing, metal stamping or medical device assembly.
• Experience with CMM, vision systems, optical measurement and advanced metrology technologies.
• Practical knowledge of SPC, MSA, Gage R&R, process capability, PFMEA and risk-based inspection methods.
• Lean Manufacturing, Six Sigma or ASQ certification (CQE, CMQ/OE).
• Experience leading inspection process optimization, automation or digital quality improvement initiatives.

What is it like to work at Cretex Medical?

We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.

Here are some of things that employees have said about working for Cretex Medical:

• “The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right.”
• “I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.”
• “I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.”

We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member.

Pay Range

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 postion.

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.