*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.
Support manufacturing and complaint handling/field sustaining leading to improved compliance with corporate policies, 21CFR820, ISO 13485, the Medical Device Directive, and other applicable regulatory agencies, while striving for continuous improvement.
NPI and Change Control Activities:
• Ensure that DMRs are complete and accurate as part of NPI/design transfer to manufacturing.
• Review ECOs and deviations according to change order guidelines, ensuring impact for Major change(s) is outlined and evidence of required activities, and reason for change is clear and accurate.
• Ensure maintenance of validated state, and consideration for re-validation during various design and process changes.
• Ensure maintenance of product ID and traceability, including that of safety critical parts.
• Review and approve the criteria for WIP reworks and re-inspections.
• Drive improvements in process capability and quality of products.
*KEY RESPONSIBILITIES *
* 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
* PREFERRED QUALIFICATIONS:
• Certified Quality Engineer
• Experience in biomedical or medical device manufacturing
• Lead Auditor certification
* Hands-on experience in statistical analysis
*TRAINING RESPONSIBILITIES: *
* Complete all assigned and required training satisfactorily and on time
For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time
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