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Senior Quality Engineer


Posted Friday, July 7, 2023

Posting ID: JP-003888670

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Bloomington, MN
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Essential Functions:

  • Manage improvement projects within Operations department
  • Propose and implement improvements utilizing the CAPA and NC systems
  • Support all departments to ensure compliance with the QMS and lead continuous improvement efforts of the QMS
  • Provide support to all quality activities (i.e. CAPA, NC, Complaint, Change Control, Validation, etc.) via risk-based approach
  • Support/Lead QMS audits (internal and external)
  • Participant in Management Review (meeting and preparation)
  • Work with Corporate Quality on projects
  • Ensure alignment between local and corporate procedures
  • Monitor quality objective status
  • May assign tasks to and direct quality engineers and other quality staff
  • May plan and coordinate detailed aspects of work within the quality department
  • Other responsibilities as required


  • Strong communication skills, written and verbal
  • Problem solving skills and utilization of tools
  • Solid understanding of ISO 13485 and 21 CFR 820
  • Detail oriented
  • Leadership skills

Desired Qualifications

Required Education:

BS Engineering and/or equivalent work experience


2-5+ years of experience in

quality engineering, quality control, quality improvement projects, root cause analysis, CAPA and/or relevant roles.

3+ years of medical device manufacturing and/or experience with 13485 preferred Certified Lead Auditor certification highly preferred (ISO 13485:2016 or ISO 9001:2015)

Experience with Notified Body Audits highly preferred

Contact Information


The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Tag icon for On-SiteOn-Site
lean manufacturing
line management
manufacturing engineering
manufacturing process
continuous improvement
equipment maintenance
medical device
process engineering
process improvement
process development
project management
quality standards
six sigma
statistical process control