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STAFF QUALITY ASSURANCE ENGINEER

GoBioJobs.com


Posted 8/9/2010 5:28:50 PM 		Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Instruments for life science research are used by scientists as they study complex biological problems including the causes of disease, identify new therapies, and test new drugs. Our customers include hospitals, physicians' offices, diagnostic reference laboratories, pharmaceutical and biotechnology companies, universities, medical schools and research institutions. In fact, Beckman Coulter has more than 200,000 clinical and research instrument systems operating in laboratories around the world.



From complex DNA sequencing to simple diagnostic screening kits, Beckman Coulter is one of the world's largest companies devoted solely to biomedical testing. The company, based in Brea, California has operations in more than 130 countries, we employ over 11,000 employees including research scientists, engineers, manufacturing associates and other professional and technical staffs. We offer opportunities for every employee to make an impact at Beckman Coulter-and on the health of people worldwide through our products which support advances in patient care.



The individual will lead the Software Quality Assurance efforts on a product team for the development of an internal remote service oriented software system.





 

  • Providing oversight and review of the software product development process and risk management concepts ensuring regulatory compliance.

     

  • Assuring product quality readiness from requirements through design transfer.



    The individual will be involved in the development, and training of corporate-level standardization in the area of software development processes and software risk management. The individual will be involved in the Team Software Process (TSP) and Personal Software Process (PSP) Q&RA Strategic initiative and would be a candidate to become a TSP/PSP instructor/coach.



    Expertise in the following areas is required for consideration:



     

  • Degree in computer science or software engineering. Chemistry, Math or related sciences a plus.

     

  • Experience BS. with 8+, M.S. with 6+ years

     

  • Demonstrated familiarity with object oriented design

     

  • Software development and software risk management experience

     

  • C++, C# and Visual Studio experience – preferred

     

  • Software Engineering Institute CMMI, TSP, and PSP experience - preferred

     

  • Conducted Six Sigma Green or Black Belt projects – preferred

     

  • Six Sigma Experience (DFSS, DMAIC) – preferred



    Demonstrated abilities for consideration:



     

  • Proven track record in software quality assurance, product development, verification, and validation

     

  • Deep understanding of software life cycle processes, especially requirements elicitation and software validation

     

  • Proficient in conducting software development process audits

     

  • FDA and ISO compliance experience (especially QSR, Part 11, Quality System Validation, IEC 12207, 62304, ISO 14971, 13485)

     

  • Experience in medical device development preferred

     

  • Strong written and verbal communication skills

     

  • Strong teaching skills

     

  • Excellent team skills and positive attitude

     

  • Multi-functional project leadership and/or people management experience



    Excellent benefits: in addition to a very competitive salary and bonus opportunity, we offer a robust benefits package that includes low cost health insurance coverage for you and your family; matching 401(k) as well as a retirement account plan; stock purchase options; paid time off (PTO) and holidays.



    If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com.


To find out more about this position, and to apply, visit Gobiojobs.com



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