Quality Engineer III- NPI

Overview

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

Position Summary:

The Quality Engineer III will support the Cretex Medical New Product Introduction (NPI) team, providing quality assurance expertise within a medical device environment. This role is responsible for defining, implementing, and improving quality-related practices, ensuring compliance with industry standards and regulatory requirements. The position will also provide technical guidance, support measurement methodologies, and contribute to the successful launch of new products.

• Quality engineering support for NPI project management
• Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality document such as control plans and inspection plans
• Support validation activity of processes, equipment, and metrology
• Analysis of process data and create validation reports
• Support and comply with the company Quality System, ISO, and medical device requirements

• Bachelor’s degree in Mechanical, Industrial, or another Engineering discipline.
• A minimum of 6 years of engineering experience in a machining or manufacturing environment.
• Strong knowledge of quality systems, regulatory requirements, and industry standards.
• Advanced proficiency in blueprint reading and Geometric Dimensioning and Tolerancing (GD&T).
• Proven expertise in metrology, including the development of inspection methods.
• Advanced statistical knowledge, including Design of Experiments (DOE) and capability studies to support process validation.
• Proficiency with statistical analysis software, particularly Minitab.

• Continuing Education; including participation in local chapters, associations, and/or organizations

Cretex Medical uses cutting oils, solvents, and other chemicals in the manufacturing process. Testing is conducted on a periodic basis to ensure that all chemicals are kept well below the OSHA permissible exposure levels.

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.

USD $90,800.00 - USD $ /Yr.

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
.

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…