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Danaher Corporation Sr. Quality Systems Specialist in Newark, California

PRIMARY RESPONSIBILITIES:

  • Drive site to compliant, timely completion of QMS activities including non-conformance, CAPA, and deviation.

  • Support the Material Review Board and work with cross-functional teams to effectively resolve non-conformances and CAPAs, including but not limited to investigating, tracking and managing action items to ensure corrective actions are effective and documented appropriately.

  • Lead and participate in interdepartmental initiatives for continuous improvement.

  • Develop and maintain Daily Management KPI metrics.

  • Generate or update written standard operating procedures to define and improve Quality System function.

  • Support internal and external audit, as needed.

  • Performs other duties as assigned.

    MINIMUM REQUIREMENTS

  • Bachelor' s degree wit h 4-6 years i n scientific , quality system , or related discipline, OR

  • Master degree with 2-4 years of related work experience.

    Knowledge and skills:

  • Excellent verbal and written communication skills in group or one-on-one settings.

  • Clear understanding of general laboratory failure investigation, qualification/validation process, root cause analysis, and troubleshooting principles.

  • Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence.

  • Computer skills: Microsoft Office: Word, Excel, Access, Power Point, Microsoft Project, Agile, SmartSolve, MES and XpertERP.

    PREFERRED QUALIFICATIONS:

  • Experience in DNA diagnostics or other medical devices

  • Experience in Kaizen, Problem Solving Process (PSP), Key Performance Indicator (KPI), Daily Management (DM), and GEMBA

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.

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