Sr. Mfg Quality Specailist
Posted on: 15 Oct 2021
Newark, CA
Job Description
POSITION SUMMARY:
Responsible for general support and managing of NC’s owned by Manufacturing and tracking of PDR’s .
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
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
Washington, DC
Danaher Corporation designs, manufactures, and markets professional, medical, industrial, and commercial products and services worldwide. The company’s Life Sciences segment provides mass spectrometers; cellular analysis, lab automation, and centrifugation instruments; microscopes; and genomics consumables. This segment also offers filtration, separation, and purification technologies to the biopharmaceutical, food and beverage, medical, aerospace, microelectronics, and general industrial sectors. Its Diagnostics segment provides chemistry, immunoassay, microbiology, and automation systems, as well as hematology and molecular diagnostics products. This segment offers analytical instruments, reagents, consumables, software, and services for hospitals, physicians’ offices, reference laboratories, and other critical care settings.
The company’s Dental segment provides consumables, equipment, and services to diagnose, treat, and prevent disease and ailments of the teeth, gums, and supporting bone. This segment offers implant systems, dental prosthetics, and associated treatment planning software; orthodontic bracket systems and lab products; endodontic systems and related consumables; restorative materials and instruments; infection prevention products; digital imaging systems and software; air and electric powered handpieces, and consumables; and treatment units.
Its Environmental & Applied Solutions segment offers instrumentation, services, and disinfection systems to analyze, treat, and manage water in residential, commercial, industrial, and natural resource applications. This segment also provides analytical instruments, software, services, and consumables for consumer, pharmaceutical, and industrial products. The company was formerly known as Diversified Mortgage Investors, Inc. and changed its name to Danaher Corporation in 1984. Danaher Corporation was founded in 1969 and is headquartered in Washington, the District of Columbia.
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IndustryManufacturing
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No. of Employees71, 000
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Website
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Jobs Posted2348
