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Quality Engineer II

Minneapolis, MN 55442

Posted: 03/13/2025 Employment Type: Contract Job Category: Engineering Job Number: 617636 Is job remote?: No Country: United States

Job Description


As a Quality Engineer II at our 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.

Must Have: Minimum Requirements –

Include: To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
  • Bachelor’s degree required in a related engineering discipline (mechanical, biomedical, manufacturing, etc.)
  • Minimum 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience.
  • Bachelor’s degree with a minimum of 2 years of relevant experience, OR an advanced degree with a minimum of 0 years of experience

Nice to Have –
  • 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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Minneapolis, MN

Ready to take the next step in your career? Explore our job opportunities in the vibrant Minneapolis, Minnesota area! Known for its picturesque lakes, thriving arts scene with renowned spots such as the Walker Art Center and Guthrie Theater, and home to the iconic Mall of America, this region offers a perfect blend of urban excitement and natural beauty. With top-tier professional sports teams like the Minnesota Vikings and Timberwolves, delicious local cuisine including Juicy Lucys and Scandinavian pastries, and an abundance of parks and outdoor activities like Minnehaha Falls and the Chain of Lakes, Minneapolis provides an unmatched quality of life for job seekers looking to grow their careers. Join us in discovering all that this charming and diverse area has to offer!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.