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Quality Engineer II - Exempt
4600 Nathan Lane North Minneapolis, MN 55442 US
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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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