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Danaher Corporation Senior Manufacturing Compliance Specialist in Sunnyvale, California

  • Initiate, investigate, evaluate and dispositions NCs related to manufacturing products and processes

  • Own NC metrics relating to overall number of NCs and NCs due to Operator Error

  • Track, trend and Action Plan to minimize NCs due to Operator Error through Daily and Visual Management.

  • Plan, facilitate and implement kaizen and sustainment activities

  • Audit existing processes and systems to assess/determine actions required for improvements.

  • Go to gemba for observations, gather evidence and to identify process improvement opportunities and drive the process improvement initiatives

  • Work cross-functionally with Manufacturing, Process Engineering, Quality Engineering and Maintenance Engineering to identify process discrepancies and improvements.

  • Work cross-functionally with the Learning and Development team to identify training gaps and drive improvements through procedure enhancements, e-learning modules and knowledge assessment

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

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

  • Maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures

  • 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

  • Chart the course of NC’s in Rework Schedule

  • Responsible for maintaining and tracking PDRs used in manufacturing

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

  • Perform other duties that are delegated by Management

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

MINIMUM REQUIREMENTS:

Education or Experience (in years):

  • Bachelor’s degree or education equivalency and 5-7 years of experience

Knowledge and skills:

  • Experience in the medical device industry, knowledge of CFR 21 Part 820 (QSR), ISO 13485.

  • Must have Process Excellence, Continuous Improvement experience (TPS, DBS, Lean Six Sigma,, etc.)

  • Broad technical knowledge of GMP systems and experience

  • Working knowledge and experience with SAP and MES

  • 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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