Quality Engineer

Summary: Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. The Quality Engineer will support the New Product Introduction team by providing quality assurance expertise and ensuring compliance with industry standards and regulatory requirements. 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 Required Qualifications: - Bachelor's degree in Mechanical, Industrial, or another Engineering discipline - 1+ 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 Qualifications: - Continuing Education; including participation in local chapters, associations, and/or organizations Required Skills: Quality engineering, New Product Introduction (NPI), Quality assurance, Medical device industry standards, Quality systems, Regulatory requirements, Blueprint reading, Geometric Dimensioning and Tolerancing (GD&T), Metrology, Inspection methods development, Statistical analysis, Design of Experiments (DOE), Capability studies, Process validation, Minitab Benefits: 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, Employee death benefit, Employee sick and safe leave, 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, Discretionary profit sharing program, Parental Leave, Accident and critical illness benefits, Optional employee, spouse, and child life, Short and long term disability, Company provided life insurance, Tuition assistance programs