Sr. Quality Assurance Engineer
Cepheid 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. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. Cepheid is an operating company of Danaher Corporation. Cepheid offers a broad array of comprehensive, competitive benefit programs that add value to associates and their families lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think youll like what you see.
Danaher is a diversified technology leader that designs, manufactures, and markets innovative products and services to professional, medical, industrial, and commercial customers. Our portfolio of premier brands is among the most highly recognized in each of the markets we serve. Danaher's portfolio is comprised of five reporting segments: Test & Measurement; Environmental; Life Sciences & Diagnostics; Dental; and Industrial Technologies. Driven by a foundation provided by the Danaher Business System, Danaher's 48,000 associates serve customers in more than 125 countries and generated $13.2 billion of revenue in 2010.
Independently plan, coordinate, and report on product quality programs, which provide a basis for sound technical decisions using techniques in experiment design and data analysis.
Provide input to budget process and project schedules.
Represent QA on development, current business or product improvement projects. Assure accuracy of product labeling and compliance.
Generate, prepare and issue complex data for assigned quality reports.
Provide input in Customer Feedback failure investigations.
Review, implement, or revise product, project, and program quality activities.
Provide design review and risk assessment expertise.
Approve the design, implementation, and schedule for QA projects.
Recommend appropriate field actions to product regulatory committees.
Accept/reject advertising, technical product, and support literature. Identify and/or perform vendor audit or site visits.
Initiate, recommend, and provide training for QA personnel.
Resolve issues of experimental design and data discrepancy in both intra and interdepartmental experiments.
BS degree in engineering, technology, or science from an accredited college or university with 5 years relevant experience OR Master's degree in field with 3 years experience OR Doctoral degree in field with 0 - 2 years experience.
Proven track record with system and or reagent product development
Fast learner, and able to quickly become adept at using the Danaher Business System tool set
Readily accepts responsibility and accountability for project success and key decisions
Strong background and experience in NPI Quality for instrumentation hardware and qualification.
Experience in the application of production and process controls including process validation, process control plans and statistical process control.
Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations.
FDA, ISO or cGMP and fast paced manufacturing area preferred.
Strong analytical skills
Effective leadership and interpersonal skills
Good written and verbal communication skills
Certified Quality Engineer or Reliability Engineer
Experience in biomedical research instrument or medical device manufacturing
Lead Auditor certification
Hands-on experience in statistical analysis