US-CA-Alameda: Quality Assurance Director

To see other opportunities, please visit http://sqa.fyicenter.com
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 organization.

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.

QUALIFICATIONS:

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.

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com