National Association of Asian American Professionals
Senior Manufacturing Compliance Specialist
Description
- 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.
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 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.
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 202.419.7762 or applyassistance@danaher.com to request accommodation.
If you've ever wondered what's within you, there's no better time to find out.
Job Information
- Job ID: 56900009
- Location:
Sunnyvale, California, United States - Position Title: Senior Manufacturing Compliance Specialist
- Company Name: Cepheid
- Job Function: Marketing