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Manufacturing Quality Specialist (3rd Shift)

Company: Cepheid
Location: Sunnyvale
Posted on: November 16, 2021

Job Description:

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


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.

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 require all US and Puerto Rico employees to be vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation as required by law.

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 to request accommodation.

If you've ever wondered what's within you, there's no better time to find out.

Keywords: Cepheid, Sunnyvale , Manufacturing Quality Specialist (3rd Shift), Other , Sunnyvale, California

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