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Title |
Location |
Type |
Rate |
Apply Now |
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Director, Systems Integration and Validation |
Boulder, Colorado |
Perm/Full |
$99,000 to $129,000 |
Submit Resume |
Director, Systems Integration and Validation
SUMMARY OF POSITION:
Responsible for ensuring that system
verification and validation testing of medical
devices consisting of software and / or hardware
produce the safety, quality and reliability
stipulated in the product requirements document.
These tests must also comply with regulatory
authorities, and notified bodies (e.g. FDA
Design Controls, QSRs and TUV).
Via subordinate supervisors and mangers oversee
and manage test engineers in their support of
V&V testing across multiple product lines.
Understand current hardware and software
industry standards and practices and FDA
regulations and their impact on internal
procedures, safety and efficacy. Ability to
interact with FDA inspectors and auditing body
agencies during audits. Must possess knowledge
and experience in product risk analysis,
requirements management and tracing, defect
tracking, and configuration management when they
are used in the development lifecycle. Provide
management and technical leadership within R&D
to effectively drive development activities in
support of the divisions goals. Establish and
monitor department goals and objectives and
ensures they are being met on time and within
budget constraints. On an ongoing basis provide
higher management with reports on project
progress and costing.
ESSENTIAL FUNCTIONS:
1. Understand current software /hardware quality
techniques, industry standards (e.g. ISO, IEEE,
CMM), and FDA Quality System Regulations and
their impact on internal procedures, safety and
efficacy of products
2. Possess knowledge and experience with
national and international QA testing standards
& techniques such as product risk assessment ISO
14971 requirements management and tracing,
configuration management, and how they are
applied in the software / hardware development
lifecycle
3. Support QA during FDA or any regulatory
agency audits.
4. Manage department resource allocation across
multiple business needs
5. Able to most effectively use inside or
outside resources to achieve goals and
objectives of GBU
6. Provide employee development and advancement
opportunities for department staff
7. Effective hiring, coaching and mentoring
skills
8. Assure staff compliance with all safety and
training requirements and certifications
9. Ability to drive change, demonstrate
effective decision making, and provide direction
for quality operations
10. Strong written and verbal communication
skills
MINIMUM REQUIREMENTS:
Education: Bachelor of Science degree in
Electronics Engineering, Mechanical Engineering,
Computer Science, or Computer Engineering. MS or
MBA degree preferred.
Experience:8+ years of management role in
software / hardware product testing and/or
quality/reliability design engineering .
Experience gained by managing multiple
departments within and/or across functions.
Preferred Skills/Qualifications: Medical Device
industry or aerospace quality assurance
experience in developing, recommending,
implementing and administering quality policy is
preferred.
Skills/Competencies: Creative problem solver,
ability to prioritize according to risk needs
Other Skills: Excellent written and verbal
communication skills
WORKING CONDITIONS:
General office, travel.
EOE
R&D
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