Quality Engineer III- NPI

Cretex Medical Component and Device Technologies • Brooklyn Park, MN

14d

About The Position

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.

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.

Nice To Haves

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

Responsibilities

• 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

Benefits

• 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.
• 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.
• 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.)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees