Senior Quality Engineer, NPI
Posted on: June 7, 2021
This position supports quality systems activities related to
hardware and reagent development in accordance with FDA and ISO
regulations. The ideal candidate will have a Quality
Systems/Quality Engineering background with knowledge of system
development lifecycles with emphasis on design control and risk
ESSENTIAL JOB RESPONSIBILITIES:
- Participate as Quality representative on select product
development teams which includes providing guidance for Market
Specification, Functional Specification, Design Verification,
Design Validation, Test Method Validation, Risk Assessments, and
Design Reviews; and provide guidance and decisions on product
development activities to ensure continued compliance with internal
procedures and applicable ISO and FDA standards.
- Provide guidance to test methods, sample plan definition, and
validation strategies to the product development teams. Resolve
issues of experimental design and data discrepancy in both intra
and interdepartmental experiments.
- Identify and drive countermeasures in instances when deviations
to the project plan occur.
- Fulfill all quality planning and risk management deliverables
with feedback from cross-functional teams. Represent the extended
Quality Systems team (including Regulatory Compliance and Supplier
Quality) to the product development teams.
- Ensure required documentation is completed prior to new product
launch, and coach product development teams to successful
completion where necessary.
- Work with management for continuous improvement of the Quality
Systems, including the design control, risk management, document
generation, and design testing processes.
- 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.
- Support on-market sustainment projects as needed.
TRAINING RESPONSIBILITIES: (REQUIRED)
- Complete all assigned and required training satisfactorily and
Education and Experience:
- Bachelor's degree with 5+ years of related work experience
- Master's degree in field with 3+ years of related work
- Doctoral degree in field with 0-2 years of work
Knowledge & Skills:
- Experience in implementing design control and risk management
activities. Strong background and experience in NPI Quality for
instrumentation and reagent qualification
- Knowledge of design of experiments. Excellent problem solving
and analytical skills. Comfortable with technical data and capable
of making risk-based recommendations, taking into account broad
perspectives that support both the regulations and the
- Effective interpersonal and communication skills, and capable
of representing Quality Systems to, and forming strong working
relationships with, functions such as Research & Development,
Engineering, Technical Operations, Regulatory Affairs, and Project
- Advanced experience with risk management and design control
- 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.
- Adept with Microsoft Word, Excel, Visio, and Minitab.
- 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.
The statements in this description represent typical elements,
criteria and general work performed. They are not intended to be an
exhaustive list of all responsibilities, duties, and skills for
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 , Senior Quality Engineer, NPI, Other , Sunnyvale, California
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