Quality Engineer Sr

Cretex • Brooklyn Park, MN

19h

About The Position

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 . Position Summary The Quality Engineer Sr will be responsible for provid ing quality assurance support for manufacturing. This position is responsible for the definition, implementation , and improvement of quality related practices and will provide technical guidance and measurement methodologies support .

Requirements

• Bachelor’s Degree in Mechanical , Industrial, or in another Engineering or Physical Science
• 10 years of experience in engineering in a molding , assembly or manufacturing setting
• Knowledge of quality systems, regulatory requirements, and industry standards
• Ability to consistently achieve short and long - term business results
• Demonstrate l eadership Skills
• Experience with ERP and quality systems
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and e ffective verbal and written communication skills
• Attention to detail
• Organizational skills
• Ability to work in a fast-paced team environment

Responsibilities

• Develop inspection requirements; facilitate PFMEAs; r esolve discrepant /non-conforming material issues and create and maintain quality document such as control plans and inspection plans
• Act as the quality interface for a production team in responding to customer complaints using failure analysis, development of corrective and preventative actions and trend analysis
• Conduct audits, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions (CAPA)
• Coach and mentor Quality Engineer levels, I, II, and III
• Subject matter expert in one or more areas of the ASQ (American Society for Quality) QE BOK (Body of Knowledge)
• Lead and participate in large company-wide projects providing quality recommendations
• Partner with sister companies to implement best practices
• Support validation activity of processes, equipment, and metrology
• Ensure business systems are implemented, maintained , and functioning properly
• Support and comply with the company Quality System, ISO, and medical device requirements
• Read, understand, and follow work instructions and standard work
• Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance

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.)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees