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Sr Software Quality Engr

Brooklyn Center, MN 55430

Posted: 04/15/2025 Employment Type: Contract Job Category: Engineering Job Number: 619127 Is job remote?: Hybrid Country: United States

Job Description


In this exciting role as a Senior Quality Engineer,  you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices within component manufacturing. This includes activities related to development, test method validation, process validation, inspection improvements, and process/quality change initiatives and much more.

Responsibilities may include the following and other duties may be assigned as required:
  • Provide Quality Engineering support for commercial medical device products.
  • Develop, modify, apply and maintain quality standards and protocols for processing materials
  • Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
  • Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Design or specify 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.
  • 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.
  • Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
  • Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
  • Present technical data to groups within and outside the organization.
  • Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.

 

 

What are the top 3 things you are looking for in a candidates experience:
  • Experience with Software Validation for equipment used in production. Experience using SPC, CAPA, NCMR, PDP processes
  • Working knowledge of Quality System Regulations such as (QSR 21 CFR 820), and ISO 13485:2016
  • Excellent verbal and written communication, analytical, influencing and interpersonal skills

 
  • Education Required: Bachelor’s Degree in Software Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality

 

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 Brooklyn Center, MN

Explore exciting job opportunities in and around Brooklyn Center, Minnesota! Nestled in Hennepin County, this vibrant area offers a perfect blend of urban conveniences and natural beauty. With easy access to the nearby Mississippi River and picturesque parks like North Mississippi Park, there are plenty of opportunities for outdoor adventures. The region boasts a rich cultural scene, from catching a show at the Historic Avalon Theater to exploring local art galleries like the Traffic Zone Center for Visual Art. Don't miss out on savoring the diverse cuisine options, from classic Midwestern dishes to trendy fusion eateries. Consider building your career in this dynamic area and discover the unique charm and growth potential Brooklyn Center 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.