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Senior Quality Engineer, NPI

Company: Danaher
Location: Sunnyvale
Posted on: June 7, 2021

Job Description:

POSITION SUMMARY:

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 management.

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 on time

MINIMUM REQUIREMENTS:

Education and Experience:

  • Bachelor's degree 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 work experience.

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 business.
  • 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 Management.
  • Advanced experience with risk management and design control principles
  • 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.
  • Adept with Microsoft Word, Excel, Visio, and Minitab.

PREFERRED QUALIFICATIONS

  • 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 this job.

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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