New Quality Engineer Job in Brooklyn Park, MN!
Position Title: Quality Engineer

Position Number: 343647

Location: Brooklyn Park, MN 55428

Position Type: Temporary

Required Skill Set:

ISO 13485, Manufacturing, Medical device, Quality Engineer

Position Description:

**C2C is not available**
**Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.**
Quality Engineer
Duration: ASAP – 8/15/2021
Location: Brooklyn Park, MN 55428

Provide Quality Engineering support to manufacturing and product development teams for mechanical devices. Implement quality improvement projects and participate in quality activities and support a factory-focus team for a production line. Provide support for released products, evaluate field returns, and support the incoming inspection department and in-process inspections where required. Perform component qualifications and validations to support key development and continuous engineering projects.

• Provide quality engineering support to manufacturing lines, including floor support, non-conforming product investigations, change order control requests reviews, and new equipment qualifications, and be a factory-focus team member.
• Perform return product investigations for product complaints.
• Monitor manufacturing quality rates and develop reports to communicate performance for manufacturing lines.
• Perform key deliverables in support of development and continuous engineering R&D projects, which include: mold tool qualifications, component qualifications, design and product risk assessments, shelf life validations, and sterilization validations.
• Work with manufacturing and R&D engineers to prepare manufacturing work instructions, material specifications, and inspection documentation for new products. Set inspection requirements, set inspection methods and inspection sampling plans.
• Support quality control inspectors with new product inspections and quality issues that arise during inspections.
• Support and test component changes to current products.
• Support internal audits and supplier audits.
• Working knowledge and understanding of mechanical drawings
• Strong problem solving, technical writing, and statistical analysis skills
• Preferred experience with supporting a manufacturing product line

• B.S. Degree in Engineering
• 3-5 years in an engineering role within a Medical Device company, 2 year minimum in Quality Engineering function.
• Must have working experience of GMP and ISO 13485 requirements.
• Sitting/standing 8 hours per day. Light lifting may be required on occasion.
• Ability to work under a microscope
• Ability to be in a clean room environment with varying humidity levels
• Ability to travel occasionally.

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Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)
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About Rose
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