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Job Title: Sr Quality Engineer-Supplier Division
Location: California, Alameda
Discipline: QA
Reference: CMMQ1115
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Description: QA & Compliance-Companywide Supplier Certification 50% travel / Alternative
Inspections Methods/ Supplier Performance Monitoring / implementation of
company-wide quality systems & policy compliance to FDA /data analysis
CMMQ1115
Sr Quality Engineer-Supplier Division
Alameda, CA
Job Description Supports in the activities used in developing, implementing
and maintaining all aspects of the Supplier Quality Engineering program to
support the needs to the corporation. Assists in the development and
implementation of supplier management programs such as Supplier
Certification, Alternative Inspections Methods, Supplier Performance
Monitoring, etc. Ensures the implementation of company-wide quality systems
and policy FDA compliance
Provides support to various operation and supply
chain activities to ensure ample coverage and support for engineering
projects and product release activities as related to supplier management. ·
Ensures the Approved Supplier List is maintained and accurate
Establish and maintain successful cross-functional relations with
Suppliers/Vendors, and internal Design & Development, Engineering,
Manufacturing, Supply Chain and Regulatory departments The position
will be required to work together with various disciplines as a team.
The position will be responsible for interpreting various quality system
requirements and for meeting those requirements on a case-by-case
basis. The position will be expected to be competent in the data analysis/
interpretation and be required to utilize such data to make data driven
decisions when providing guidance, recommendations and decisions.
Additionally, the R&D QA Engineer will provide guidance with respect to
quality analysis and guidance for the decision making process associated
with supplier/vendor relationships / Ensures the ADC Approved
Supplier List is maintained and accurate. ·
Qualifications: Minimum Requirements
-Education Requirements Bachelor's Degree in Life Sciences, Physical
Sciences
or Engineering disciplines
-7-9 years Quality Assurance experience in the
medical device manufacturing or pharmaceutical industries.
-Working knowledge applicable regulations and standards
such as FDA QSR, ISO, MDD, & IVDD.
·Well developed written, oral and interpersonal skills.
-Experienced lead assessor in conducting external assessments.
-Strong analytical skills, problem solving techniques and statistical
application experience.
-Knowledge in the areas of Design Controls
-Percentage of Travel 50 %
Apply to: Click Here
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