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"The GxP Family of
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"We stand on a higher pillar of excellence!"
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Title |
Location |
Type |
Rate |
Apply |
| Software QA
Engineering Manager |
Boulder, CO |
Perm/Full |
$85,000 -
$98,000 |
Submit |
Software QA
Engineering Manager
ESSENTIAL FUNCTIONS:
• Oversee and manage Software Quality Assurance
Engineers ensuring that software used in the
development, manufacturing, and as part of
medical devices is developed according to good
design practices and follows the corresponding
requirements set forth by local procedures,
regulatory authorities and notified bodies.
(e.g. FDA and TUV).
• Manage Manufacturing Software Quality Engineer
providing oversight, review and approval of
manufacturing division computerized system
validations.
• Manage department resource allocation across
multiple product lines.
• Write software process procedures and guidance
documentation for software development
lifecycle.
• Interact with FDA inspectors and auditing body
agencies during audits.
• Drive change, demonstrate effective decision
making, and provide direction for quality
operations.
• Provide guidance and advancement opportunities
for department employees.
Requirements Minimum Requirements:
Education: Bachelor of Science degree in
Electronics Engineering, Computer Science, or
Computer Engineering
Experience: 8 to 10 years in software test or
software quality engineering or management role
Skills/Competencies: Working knowledge of and
auditing experience to the FDA Quality System
Regulation, ISO 13485, and the Medical Device
Directive
Skilled in product risk assessment (ISO 14971),
requirements management and tracing, defect
tracking, configuration management techniques,
and how they are applied in the software
development lifecycle
Understand current Software Quality techniques,
software industry standards (e.g. ISO, IEEE,
CMMI), and FDA Quality System Regulations and
their impact on internal procedures, software
quality, safety and efficacy of products.
Working knowledge of C, C++
Good verbal (including presentation) and written
communication skills
Effective coaching and mentoring skills
CSQE Certification
Preferred Skills/Qualifications: Understanding
of Object Oriented programming techniques
Working knowledge of Unified Model Language (UML)
Other Skills: Spanish proficiency desirable
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