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Staff Quality Assurance Engineer

Beckman Coulter Life Sciences

Indianapolis, IN
3 days ago

Job Description

Join Beckman Coulter Life Sciences as a Staff Quality Assurance Engineer, where you'll play a key role in ensuring product quality and compliance across various projects. Collaborate cross-functionally and utilize your expertise to drive quality improvements in life-saving technologies.

Key Responsibilities

  • Representing quality assurance on development teams, quality systems, and product improvement projects
  • Coaching teams with application of ISO 9001/13485/cGMP/IEC 62304 and quality systems processes
  • Partnering cross-functionally to ensure product and service conformance
  • Assuring compliant process and product documentation
  • Awareness of current industry standards and regulations

Required Qualifications

  • Degree in engineering or science or related field
  • BS+7 or MS+4 years’ experience in product development, manufacturing and/or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, or other regulated industries

Preferred Qualifications

  • Ability to identify, develop and execute quality system, product and process improvements
  • Certified Software or Quality Engineer (SQA) preferred and/or Auditor Certification desired
  • Experience with product software development lifecycle management

Benefits & Perks

Comprehensive health care programsPaid time off