Quality Engineer III
Job Description
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 www.cretexmedical.com. 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. Responsibilities Quality engineering support for NPI project management Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality documents 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 Qualifications 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.
Preferred Requirements
Continuing Education; including participation in local chapters, associations, and/or organizations
Physical & Environmental Demands: 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. Pay Range USD $89,000.00 - USD $111,300.00 /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.
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