What are the responsibilities and job description for the Quality Engineer Sr - Molding and Assembly position at Cretex Medical Component and Device Technologies?
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.
Postion Summary
The Senior Quality Engineer is a critical member of the Quality team responsible for supporting manufacturing operations, managing quality systems, supporting customers, and leading quality improvement initiatives. This position plays a key role in defining, implementing, and improving quality-related practices and is a technical subject matter expert in measurement methodology, validation, and root cause analysis. The Senior Quality Engineer serves as a mentor to engineers and drives continuous improvement across molding and assembly operations in compliance with ISO 13485 and FDA 21 CFR Part 820.
Responsibilities
Manufacturing Quality Support
- Serve as the primary quality interface for production teams and support day-to-day operations.
- Lead and support resolution of non-conforming product, material review board activities, and deviation approvals.
- Develop, implement, and maintain PFMEAs, Control Plans, and detailed inspection plans.
- Define and optimize inspection methodologies in collaboration with programming and Inspection teams.
Customer & Supplier Management
- Lead customer complaint investigations using structured problem-solving tools (5 Whys, Fishbone, etc.).
- Create and execute CAPAs, monitor trends, and ensure effectiveness of actions.
- Represent quality in customer meetings, audits, and technical reviews.
- Work with suppliers to address quality concerns, support audits, and improve incoming part quality.
Validation & Measurement Expertise
- Lead or support validation of processes, tooling, equipment, and inspection methods (IQ/OQ/PQ).
- Conduct measurement system analysis (MSA), including Gage R&R, and support capability studies (Cp, Cpk).
- Create validation protocols and analyze results to ensure process capability and control.
Compliance & Auditing
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and customer-specific requirements.
- Participate in internal and external audits; close out findings and ensure QMS adherence.
- Drive audit readiness and timely closure of finding or observations.
Leadership & Strategic Initiatives
- Mentor and coach Quality Engineers I, II, and III; provide guidance on technical and regulatory topics.
- Act as a subject matter expert in one or more areas of Quality tools, such as root cause analysis, process capability, SPC, DOE and Lean Six Sigma.
- Lead and participate in continues improvement projects to implement best practices and drive systemic improvements.
- Champion Operational Excellence and Lean Six Sigma initiatives.
Qualifications
- Bachelor’s degree in Mechanical, Industrial, or another Engineering or Physical Science discipline.
- Minimum 10 years of engineering experience in a manufacturing or regulated environment (medical device preferred).
- Deep knowledge of ISO 13485, FDA 21 CFR Part 820, and risk-based quality systems.
- Proficiency in GD&T, blueprint reading, SPC, and quality engineering tools (Minitab, DOE, capability studies).
- Strong verbal and written communication skills and ability to collaborate cross-functionally.
- Experience with ERP and QMS platforms (IQMS, EPICOR and ETQ preferred).
- Demonstrated leadership in coaching, mentoring, and project execution.
Senior Quality Engineer Preferred Requirements:
- ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt.
- Experience in injection molding and/or device assembly.
- Vision system and CMM programing experience (e.g., MicroVu, OGP, CMM).
- Knowledge of Design for Manufacturability (DFM)
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
USD $97,900.00 - USD $122,400.00 /Yr.Company Benefits
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.
Salary : $97,900 - $122,400