US-CA-Alameda: Quality Assurance Director

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US-CA-Alameda: Quality Assurance Director
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Date: 14-Apr-2009

Quality Assurance Director

MAJOR RESPONSIBILITIES: 1. Responsible for establishing, implementing,
and maintaining the Design Control, Document Control, Quality Control,
Validation and Quality Engineering systems in accordance with division
requirements, ISO standards, and applicable regulations.

2. Ensure, through personal involvement and through others, that the
impact of new products or design changes are understood throughout the

3. Identify organizational development needs and establish plans to
assure that skills of group keep pace with business growth and change

4. Establishing, implementing, and maintaining the organizational
structure to support the quality system, and management review of the
quality system to determine its effectiveness.

5. Oversight and support of validation and calibration activities, and
operations quality functions.

6. Responsible for participating on Quality Review Board, External
Inspections and other divisional activities as required.

ACCOUNTABILITY / SCOPE: - Responsible for ensuring that new product
and existing product design change activities are appropriately
documented and released. Responsible for overall product quality
related to ADC designed products as well as products manufactured for
ADC by OEM vendors or or products designed for ADC by design houses.
Failure to meet these requirements can result in product recalls,
warning letters, and potential user injury. Long term failure of
effective product quality will result in decreased revenues.


Basic Qualifications: - 10-15 years of Quality Assurance experience in
a manufacturing environment. Minimum 5 years in the medical device
industry. Minimum 5 years experience managing/leading organizations. -
Firm knowledge of QSR, ISO, EN Quality System Requirements -
Demonstrated experience with development, implementation and
management of company-wide Quality Systems. - Highly developed
written, oral and interpersonal skills. - CQE, CQA or CQM via ASQ a
plus - Proficient with use of various software applications such as MS
Word, Excel, Access, PowerPoint, Solidworks, etc.

Knowledge and prior experience in corrective and preventive action
systems, ISO standards and guidance documents and the FDA QS
regulation are required. Prior experience in the medical device and/or
in-vitro diagnostic industry also required. Prior supervisory and
management experience required.

Thank you,
Team SQAFYI - Software QA Resource FYI

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