|
|
|
|
|
|
|
|
|
|
|
|
Boston Scientific
QA Director (Capital Equipment) - 21205
Location: Fremont,
California
00000
Posted on:
6/30/2007 8:12:54 AM
Postion type:
Full time
Job Code:
21205
Required Education:
Salary:
DESCRIPTION
General Summary:
The Director of Quality Assurance is responsible for the administration, supervision, and development of the Quality Department for Capital Equipment.
Specific Duties and Responsibilities:
The Director of Quality Assurance is the Management Representative for the Fremont site, supporting the Neurovascular Division and/or Imaging Franchise and Field Service group. The Director of Quality Assurance is responsible for representing the facility to all external Quality System Assessment agencies, such as Notified Body Representatives, Federal Food and Drug Agency Inspectors, and Corporate Quality Compliance Auditors. The Director of Quality is a member of the Senior Management Teams and the Project Investment Boards (PIB).
Develop and implement procedures and systems to assure BSC-SJ complies with applicable regulatory standards.
Develop and implement methods and systems to assure that development as well as production teams receive support in the following areas:
• Quality planning, including inspection techniques and sampling methods
• Statistical analysis
• Biological testing including sterilization
• Application of required regulatory standards
Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum:
• Delivery of raw materials and OEM products.
• Manufactured devices and equipment.
• Documentation associated with these functions
Develop, track, and report on the following administrative systems:
• Budget
• Department metrics
• Department objectives
• Personnel development and training
Develop and implement divisional business and operational strategies
Position Qualifications:
The Director of Quality Assurance is required to have a minimum of a Bachelor’s Degree, preferably in a technical field such as engineering or physical sciences, as well as 8 years working experience within the medical device industry or an equivalent combination of education and experience in the field of Quality Assurance. ~MDC
REQUIREMENTS:
See Above
|
|
 |
|
|
|
|
|
|
|
|
|