Sr. Quality Operations Engineer
Posted on: June 6, 2021
- Generate, prepare and issue complex data for assigned quality
- Provide input in Customer Feedback failure investigations.
- Review, implement, or revise product, project, and program
- Approve the design, implementation, and schedule for QA
- Recommend appropriate field actions to product regulatory
- 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
- Coach and develop extended Quality team members as necessary to
assure common understanding of the product development process and
- 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
- 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
- Experience representing their department during quality system
- 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
- 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
- High degree of initiative and self-motivation.
- Strong analytical and problem-solving skills.
- Proficient with Microsoft Office (Word, Excel,
- Complete all assigned and required training satisfactorily and
- 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
- Master's degree in field with 3+ years of related work
- Doctoral degree in field with 0-2 years of related work
- 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
- 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.
Keywords: Danaher, Sunnyvale , Sr. Quality Operations Engineer, Other , Sunnyvale, California
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