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Danaher Corporation Sr. Manufacturing Quality Specialist in Sunnyvale, California

ESSENTIAL JOB RESPONSIBILITIES:

  • Perform technical duties related to initiating a NC (Non-conformance report) identified by Manufacturing.

  • Assist P.E, M.E and F.I on generating, investigating, disposition on any NC request that pertains to or impacts Manufacturing

  • Oversee and assist in segregation of non-conforming material physically and systematically as required per Procedures

  • Oversee implementation of NC disposition actions in Manufacturing

  • Provide work instructions for NC’s for Manufacturing when requested by any NC evaluator

  • Responsible for maintaining and tracking manufacturing-owned NC’s in all phases of the process

  • Chart the course of NC’s in Rework Schedule

  • Ensure NC’s form and in eQMS meet Procedure standard

  • Responsible for maintaining and tracking PDRs used in manufacturing

  • Responsible to drive any concerns from Manufacturing with any signed of NC’s and PDR’s

  • Prepare and present NC’s reports owned by Manufacturing

  • Perform interview’s with Associates when an NC’s is initiated

  • Evaluate any NC assigned to Manufacturing

  • Work closely with Document Specialist to redline any necessary changes to SOPs as action items by NC’s

  • Work with Master Planners to drive completion dates on NC’s reworks

  • Support Manufacturing Consumables on any NC request

  • Support Manufacturing ROBAL Fill/Pack with OC daily report and Inventory report

  • Attend and Drive meetings with NC’s

  • Train new and regular Associates on eQMS

  • Work closely with Quality Department in eQMS

  • Monitor and upload PDRs and NC’s in CAMSTAR for Manufacturing

  • Perform other duties that are delegated by Management

  • Work on varies projects e.g. Kaizen’s, Shin Events, Just do it

  • Audit Manufacturing area to ensure Associates following SOP’s

MINIMUM REQUIREMENTS:

Education or Experience (in years):

  • Associates degree or education equivalency and 2-5 years of experience

Knowledge and skills:

  • Broad technical knowledge of GMP systems and experience

  • Understand manufacturing process and quality systems

  • Proficient technical writing skills

  • Ability to effectively and professionally communicate through verbal and written communication

  • Computer skills, e.g., Microsoft Office,Microsoft Excel , electronic documentation system, ERP systems,eQMS

Physical requirements/abilities:

  • Must be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm/wrist motions.

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) .

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