Beckman Coulter Life Sciences
Staff Quality Assurance Engineer
Beckman Coulter Life Sciences, Indianapolis, Indiana, us, 46262
Overview
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Staff Quality Assurance Engineer
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Beckman Coulter Life Sciences . Beckman Coulter Life Sciences, one of Danaher’s operating companies, focuses on innovations that save lives. We are committed to continuous improvement and turning ideas into impact. We value time in the laboratory and strive to accelerate answers through automation and cross-functional collaboration. The Staff Quality Assurance Engineer or Scientist is responsible for facilitating the application of quality system and design control processes with teams across Beckman Coulter Life Science 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 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 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
The Essential Requirements Of The Job Include Degree in engineering or other science or related field; or equivalent experience required. 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. It would be a plus if you also possess previous experience in 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. Role details
Beckman Coulter Life Sciences, a Danaher operating company, offers comprehensive benefit programs. Join our team to advance human health for tomorrow. Location and on-site requirement
Location: Indianapolis, IN. This is an on-site role. Job metadata
Seniority level : Not Applicable Employment type : Full-time Job function : Engineering and Information Technology EEO notice: 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. Reasonable accommodations are available for applicants with disabilities. For accommodation requests, contact: 1-202-419-7762 or applyassistance@danaher.com.
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Join to apply for the
Staff Quality Assurance Engineer
role at
Beckman Coulter Life Sciences . Beckman Coulter Life Sciences, one of Danaher’s operating companies, focuses on innovations that save lives. We are committed to continuous improvement and turning ideas into impact. We value time in the laboratory and strive to accelerate answers through automation and cross-functional collaboration. The Staff Quality Assurance Engineer or Scientist is responsible for facilitating the application of quality system and design control processes with teams across Beckman Coulter Life Science 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 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 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
The Essential Requirements Of The Job Include Degree in engineering or other science or related field; or equivalent experience required. 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. It would be a plus if you also possess previous experience in 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. Role details
Beckman Coulter Life Sciences, a Danaher operating company, offers comprehensive benefit programs. Join our team to advance human health for tomorrow. Location and on-site requirement
Location: Indianapolis, IN. This is an on-site role. Job metadata
Seniority level : Not Applicable Employment type : Full-time Job function : Engineering and Information Technology EEO notice: 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. Reasonable accommodations are available for applicants with disabilities. For accommodation requests, contact: 1-202-419-7762 or applyassistance@danaher.com.
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