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Sr Quality Engineer

Brooklyn Park, MN 55428

Posted: 04/07/2026 Employment Type: Contract Job Category: Engineering Job Number: 626197 Is job remote?: No Country: United States

Job Description


Additional position details from the manager below:
  1. Can you please confirm your top 3 skills sets required?  Validation, Technical Writing, Problem Solving
  2. Can you please confirm the 3 main responsibilities/day to day activities required for this role?  Validation Gap Assessment, Change order creation and documentation update, Revalidation/remediation activities to close gap assessments
  3. What products (if any) will this role support?  Fusion Hollow Fiber Oxygenator (HFO) and Cardiotomy Venous Reservoirs (CVR)
  4. What is your target years of experience?  5-15
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.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

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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About Brooklyn Park, MN

Discover exciting job opportunities in and around Brooklyn Park, Minnesota, awaiting your expertise and talents. This vibrant area, nestled in Hennepin County, boasts a thriving economy with a diverse range of industries offering tremendous growth potential. Consider kickstarting your career in this dynamic region known for its enchanting charm, picturesque parks like Elm Creek Park Reserve, acclaimed art galleries such as Banfill-Locke Center for the Arts, and the historic Edinburgh USA Golf Course. Enjoy a delicious journey through the local cuisine, from beloved eateries like Fat Nat's Eggs to the abundance of farm-to-table options at local restaurants. Embrace the unique culture of the area while catching a performance at the Park Square Theatre or rooting for the Minnesota Vikings at the U.S. Bank Stadium. Join us in exploring the wealth of opportunities that Brooklyn Park and its surroundings have to offer, and unlock your professional potential in this thriving community.