Danaher Corporation Sr. Quality Operations Engineer in Sunnyvale, California
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 it´s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you´ll 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.
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.
Approve the design, implementation, and schedule for QA projects.
Recommend appropriate field actions to product regulatory committees.
Resolve issues of experimental design and data discrepancy in both intra and interdepartmental experiments.
Support project core teams throughout the phase gate process for new product development and ensure compliance to Cepheid and Danaher policies and procedures.
Establish and monitor use of risk assessment tools for project tracking and management
Assure project adherence to Design Controls to deliver robust, manufacturable products which meet the defined delivery timeline, design inputs and quality metrics to meet business unit goals.
Identify and drive countermeasures in instances when deviations to the project plan occur.
Work effectively with all team members, stakeholders and supervisor
Coach and develop extended Quality team members as necessary to assure common understanding of the product development process and project goals
Effectively communicate and maintain visual tools for project tracking and management
Effectively employ Danaher Business System (DBS) tools and concepts to maximize efficiency and quality.
Typically serves as a project or team leader for a complex business concept or application.
Influence the development of others as project leader.
Works with team members to develop team goals and plans, resolve problems and achieve goals.
Knowledge and skills:
• 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.
• Advanced experience with risk management and design control principles
• Experience representing their department during quality system audits.
• Self-starter with a demonstrated ability to focus efforts, overcome obstacles and complete key projects
• Communication skills, both oral and written.
• Ability to work effectively in a team environment and build strong working relationships.
• Ability to constructively challenge concerns and engage in transparent conversations.
• Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence.
• Foster an environment that values diversity and inclusion.
• Strong attention to detail. Ability to successfully balance and prioritize multiple on-going projects/tasks (Project Management skills).
• High degree of initiative and self-motivation.
• Strong analytical and problem-solving skills.
• Proficient with Microsoft Office (Word, Excel, PowerPoint).
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.
Bachelor’s degree in field with 5+ years of related work experience OR
Master’s degree in field with 3+ years of related work experience OR
Doctoral degree in field with 0-2 years of related work experience
Experience in the medical device industry, knowledge of CFR 21 Part 820 (QSR), ISO 13485.
A quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations. Examples include the CQE, CRE, CQA, etc.
Certified in Lean manufacturing and/or Six Sigma
Experience in product mechanical evaluation & testing and GD&T
Hands-on experience in advance statistical analysis
Experience in injection plastic molding processes.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
Operating Company: Cepheid