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Staff Quality Assurance Engineer

Beckman Coulter Life Sciences

Indianapolis, IN
3 days ago

Job Description

As a Staff Quality Assurance Engineer at Beckman Coulter Life Sciences, you will drive quality assurance efforts within product development and manufacturing. Collaborate with teams to implement quality systems, ensuring compliance and enhancing product lifecycle processes to positively impact human health.

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
  • Influencing interpretation of internal policies and procedures to ensure quality and compliance

Required Qualifications

  • Degree in engineering or other science or related field; or equivalent experience
  • BS+7 or MS+4 years’ experience in product development, manufacturing and/or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences 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 programPaid time off