Quality Systems Specialist I (3rd Shift)
Posted on: January 5, 2022
- Review records and documents for completeness and compliance
with QSR and ISO requirements.
- Create Certificate of Conformances for each lot released.
- Review the QC measurement data and upload the data and
Certificate of Conformance into an on-line database for each
- Create and apply approval labels for release products.
- Coordinate with the Shipping Department the shipping of release
parts to the production facilities.
- Perform material movement and release transactions in the
company s ERP system.
- Create and Maintain inventory of retains samples that are
- Assist with corrective action activities in the resolution of
- Support the Material Review Board, for the assessment and
disposition of non-conforming materials and closure of
Non-conformance and Deviation Reports.
- Participate in interdepartmental initiatives for continuous
- Generate standard operating procedures to define and improve
quality system functions.
- Support QS Manager to implement and monitor Manufacturing and
Quality Systems procedure.
- Review records and documents, for completeness and compliance
with QSR and ISO requirements.
- Support the eDMS electronic documentation process as
needed.Education and Experience (in years):
- High school diploma with at least 2 years of work experience in
a manufacturing environment.
- Must be familiar with ISO standards and applicable regulatory
requirements (CE/FDA/QSR)REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Excellent verbal and written communication skills in group or
- Computer skills, e.g., word, excel, access, Microsoft project,
electronic documentation systems.
- Ability to interface well with people of varied backgrounds,
and to guide groups toward effective dynamics.
- Understanding of general mathematical principles and
calculations, at college entry level.
- Experience in compiling data to support metrics analyzing
- Understanding root cause analysis, failure analysis and general
troubleshooting principles, and the ability to transfer those
skills to others, either individually or in a group setting.
- Detailed and quality oriented.
- Strong organizational skills.TRAINING RESPONSIBILITIES:
- Complete all assigned and required training satisfactorily and
on timePREFERRED QUALIFICATIONS (optional):
- Experience in DNA diagnostics or other medical devices
- Associate s degree a plus but not required.PHYSICAL DEMANDS
- Ability to work in an office environment
- Maintain flexibility in work schedule as interface with
personnel on 2nd and weekends shifts are required.
- Frequent walking between locationsWhen 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
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 .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. Associated topics: attorney, attorney corporate, business,
compliance, compliance department, corporate attorney, court,
internal, llp, market
Keywords: Cepheid, Lodi , Quality Systems Specialist I (3rd Shift), Other , Lodi, California
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