Description

(Duties and Responsibilities:
Provide Supplier Quality Support for assessment of Corporate external software suppliers involved in delivering either Software Development Services or Software solutions
Provide guidance to other BSC facilities to develop individual expertise to support Plant software assessment support
Develop and Refine Software Supplier Assessment policies and procedures as needed to maintain compliance with changing industry and regulatory trends.
Skills required:
Able to support medical device development teams on complying with regulatory requirements.
Able to assess software development life cycle deliverables with externals providers.
Able to scrutinize external suppliers software development validation deliverables for compliance with regulatory requirements.
Excellent interpersonal skills needed to manage and resolve issues from different business cultures.
Ability to work well with internal resources as well as suppliers.
In-depth knowledge of a good SDLC process within the device design control process.
Fundamental knowledge of ANSI/AAMI SW-68 and the implementation of this standards requirements as applicable to external manufacturers.
Fundamental knowledge of the FDA General Principles of Software Validation.
Fundamental understanding of software/system configuration management and change control.
Fundamental understanding of GMP/QSR requirements preferred. ~MDC
Education and Experience:
Experience with hospital networks and patient database management systems a plus
5 - 10 years experience in software sciences in code development, validation and test
2 to 5 years experience in a medical device industry
Bachelors degree required

Requirements

See Above