Danaher Life Sciences
Overview
The Staff Quality Assurance Engineer or Scientist is responsible for facilitating application of quality system and design control processes with teams across Beckman Coulter Life Sciences products including instrumentation, software and consumables. This position reports to the Jim Taller and is part of the Development Quality Team located in Indianapolis and will be an on-site role. Responsibilities
Representing quality assurance on development teams, quality systems and product improvement projects for Beckman Coulter Life Science. Coaching teams on the application of ISO 9001/13485/cGMP/IEC 62304 and quality systems processes throughout the product lifecycle. Partnering cross-functionally to ensure product and service conformance with particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), Production, Service Controls. Assuring compliant process and product documentation, inclusive of Design History, Product, Process and Service documentation in support of product realization and commercialization within the Beckman Coulter quality system. Awareness of current industry standards and regulations and how they relate to internal policies and procedures. Influences interpretation of internal policies and procedures to ensure quality and compliance. Qualifications
Degree in engineering or other science or related field; or equivalent experience required. BS with 7+ years or MS with 4+ years of experience in product development, manufacturing and/or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other regulated industries. Ability to identify, develop and execute quality system, product and process improvements and drive change across multi-site operations. Certified Software or Quality Engineer (SQA) preferred and/or Auditor Certification desired. Experience with product software development lifecycle management. Benefits
Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Check out our benefits at Danaher Benefits. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or applyassistance@danaher.com. Seniority level
Mid-Senior level Employment type
Full-time Job function
Engineering and Information Technology Industries
Biotechnology Referrals increase your chances of interviewing at Danaher Life Sciences by 2x.
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The Staff Quality Assurance Engineer or Scientist is responsible for facilitating application of quality system and design control processes with teams across Beckman Coulter Life Sciences products including instrumentation, software and consumables. This position reports to the Jim Taller and is part of the Development Quality Team located in Indianapolis and will be an on-site role. Responsibilities
Representing quality assurance on development teams, quality systems and product improvement projects for Beckman Coulter Life Science. Coaching teams on the application of ISO 9001/13485/cGMP/IEC 62304 and quality systems processes throughout the product lifecycle. Partnering cross-functionally to ensure product and service conformance with particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), Production, Service Controls. Assuring compliant process and product documentation, inclusive of Design History, Product, Process and Service documentation in support of product realization and commercialization within the Beckman Coulter quality system. Awareness of current industry standards and regulations and how they relate to internal policies and procedures. Influences interpretation of internal policies and procedures to ensure quality and compliance. Qualifications
Degree in engineering or other science or related field; or equivalent experience required. BS with 7+ years or MS with 4+ years of experience in product development, manufacturing and/or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other regulated industries. Ability to identify, develop and execute quality system, product and process improvements and drive change across multi-site operations. Certified Software or Quality Engineer (SQA) preferred and/or Auditor Certification desired. Experience with product software development lifecycle management. Benefits
Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Check out our benefits at Danaher Benefits. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or applyassistance@danaher.com. Seniority level
Mid-Senior level Employment type
Full-time Job function
Engineering and Information Technology Industries
Biotechnology Referrals increase your chances of interviewing at Danaher Life Sciences by 2x.
#J-18808-Ljbffr