B

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 will facilitate quality systems and design control processes across innovative life science products. This role is pivotal in ensuring compliance and enhancing product quality, directly impacting the delivery of life-saving therapies.

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 throughout product lifecycle
  • 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
  • Driving change cross-functionally across multi-site operations
  • 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 offCompetitive benefit programs