Sr Quality Systems Spec

Brooklyn Center, MN 55430

Posted: 10/31/2025 Employment Type: Contract Job Category: Quality and Compliance Job Number: 623510 Is job remote?: No Country: United States

Job Description


HM's Top Needs:

1.  Experience in medical device, pharmaceutical and/or a regulated environment.

2.  Experience in large scale projects with interaction across numerous functions and stakeholders.

3.  Experience in quality system management.
 

Education Required:

Years’ Experience Required:
  • Requires a Bachelors degree and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.

 
  • Responsibilities:
  • Work with a core team responsible for integration of QMS processes across multiple locations.
  • Review interactions between elements of the QMS and work with key stakeholders in Development, Operations, Quality, and Supply Chain Management to ensure robust processes that ensure quality and compliance while driving business efficiency.
  • Working with the program manager to evaluate, plan, and execute updates to QMS procedures, quality manuals, quality plans, quality agreements, and certifications.
  • Evaluate and coordinate with impacted functions to determine appropriate training.
  • Must Have: Minimum Experience
  • Requires a Bachelors degree and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
  • Familiarity with Microsoft Office suite of applications.
  • Nice To Have:
  • Lean / Six Sigma certification.
  • Experience in project management and risk mitigation.
  • Experience in acquisitions or mergers.
  • Experience in medical device, pharmaceutical and/or a regulated environment.
  • Understanding of FDA regulations (21 CFR 820 and Part 11) and ISO 13485.
  • Strong analytical, process improvement, critical thinking, and decision-making skills.
  • Familiarity using Product Lifecycle Management (PLM) applications (Agile, Windchill).
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

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.