Senior Quality Systems Engineer

Integer Wilmington , NC 28412

Posted 3 weeks ago

At Integer, our vision and values are embedded in everything we do!

If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!

  • Do you have a passion for quality systems?
  • Are you looking to join one of the top medical device quality organizations?
  • Are you a natural problem solver?

If you answered yes, we'd love to speak with you. Integer is hiring for a Senior Quality Systems Engineer.


Accountabilities &

Responsibilities:
  • Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.

  • Leads the execution and improvement of quality assurance and quality systems activities.

  • Develops and manages quality systems that comply with national and global regulatory requirements.

  • May lead and conduct detailed quality analyses including cost of quality trends and root cause analyses.

  • Develops new and unique approaches to complex problems and advance technology beyond previous company involvement.

  • Plans/develops engineering projects concerned with unique or high-profile problems which have important effect on major organization programs.

  • Provides management with technical guidance as required.

  • Identifies and procures the appropriate process equipment.

  • Investigates, develops and implements new process technologies of major scope.

  • Maintains liaison with individuals and business units within or outside his/her organization with responsibility for acting independently on technical matters pertaining to his/her field.

  • Subject matter expert in engineering specialty/application.

  • Performs other duties as required.

Minimum Education & Experience:

  • Bachelor's degree required (technical discipline preferred)

  • 7+ years Quality Assurance and Compliance in the Medical Device, Pharmaceutical, or Diagnostics industry

  • Specialized Knowledge:
    Strong understanding of applicable regulations and standards (21 CFR 803, 806, and 820, and ISO 13485). Problem Solving and training skills.

  • Special Skills:
    Proficient in Microsoft Office applications required. Familiarity with eQMS Programs (TrackWise, EtQ, etc.) desired.

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Senior Quality Systems Engineer

Integer