Quality Engineer II

Primary Talent Partners has a 12 month contract opening for a Quality Engineer II to join a multinational medical device company for an onsite position operating out of Plymouth, MN. 

Pay: $40.00/hr - $50.00/hr based on experience and academia
Contract: 12 months, extensions likely, conversion possible
Type: W-2, cannot support C2C or provide visa sponsorship

Summary / Responsibilities:

As a Quality Engineer II at our Nathan Lane Manufacturing site, you will be at the forefront of driving excellence in our products and processes. You’ll leverage your experience to ensure our life-changing therapies meet the highest standards of quality, compliance, and reliability. This role requires you to be onsite Monday through Friday, providing you the opportunity to collaborate closely with cross-functional teams in a fast-paced, hands-on environment. 

Responsibilities may include the following and other duties may be assigned.

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Required Qualifications

• Bachelor’s degree required in a related engineering discipline (mechanical, biomedical, manufacturing, etc.)
• Minimum of 2-3 years of experience in problem solving, root cause analysis, and good technical writing. 

Preferred Qualifications:

• Experience reviewing technical documentation
• Previous process validation experience (including installation qualifications, process characterization, operational and performance qualifications)
• Previous experience with developing, executing, and analysis of Test Method Validations
• Previous experience with Master Validation Records and Risk Management documentation (including DFMEA and PFMEA)
• Strong written and verbal communication skills
• Strong critical thinking and analytical skills
• CAPA NCMR knowledge
  

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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