Quality Engineer II
Job description
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.
Responsibilities:Position summary
The Quality Engineer II will be responsible for providing 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.
Essential Job Functions
- Quality engineering support for manufacturing and project management
- Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality document such as control plans and inspection plans
- Analyze data and identify improvement opportunities
- 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
- Lead and participate in intermediate company projects providing quality recommendations
- Support validation activity of processes, equipment, and metrology
- Create protocols and analyze data
- Support the Quality Inspectors to ensure that inspection plans comply with the relevant requirements of customer’s product requirements
- Support and comply with the company Quality System, ISO, and medical device requirements
Minimum Requirements, Education & Experience (incl. KSA’s and certifications)
Bachelor’s Degree in Mechanical, Industrial, or in another Engineering Science- 3 years of experience in engineering in a machining or manufacturing setting
- Knowledge of quality systems, regulatory requirements, and industry standards
- Intermediate knowledge of blueprint reading and GD&T
- Ability to operate a variety of inspection equipment
- Statistical expertise with DOE and Capability Studies
- Design software- Minitab
- Process management
Desirable Criteria & Qualifications
- Continuing Education; including participation in local chapters, associations, and/or organizations
Physical & Environmental Demands
Cretex Companies may use 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.
“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.”
Company Benefits
Cretex Medical also offers company-specific benefits, such as:
- Employee Appreciation events
- Volunteer Opportunities
- Training and Development opportunities
- Tuition Reimbursement
- New state-of-the-art facility in Brooklyn Park!
Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify .
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