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
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
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) .