Software Design QA
4040 Nelson Ave Concord, California 94520
Position: Software Design Quality Assurance
Location: Concord, CA
Type: contract until June 2020
Interview Expectations: Phone and In Person
PURPOSE AND SCOPE:
Participate in software development and verification in New Product Development and design changes. Ensure all software for functional completeness, internal design control procedures and regulatory compliance.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
• A seasoned, experienced professional with understanding of IEC62304, ISO14791, and design control process; resolves a wide range of issues in creative ways.
• Work with project managers and cross functional team to ensure products meet customer expectations, and regulatory requirements.
• Provide guidance to engineering staff to ensure SDLC and design control requirements are being met in an effective manner, including full range design verification, validation, risk management, and design review.
• Review requirements, specifications and technical design documents to provide timely and meaningful feedback.
• Drive risk analysis and FMEA deliverables with engineering staff to ensure product safety and efficacy.
• Review test protocols and reports at multiple levels to ensure the accuracy and completeness of test cases.
• Provide guidance to project teams to document thoroughly and track bugs.
• Provide guidance to perform thorough regression testing when bugs are resolved.
• Identify procedure improvement opportunities for SDLC and drive the implementation.
• Review and approve design control related Change Notices (CNs) within the documentation system.
• Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards.
• Represent the design quality assurance department to FDA, ISO and all other auditors.
• Work independently on high visibility new product development projects; including projects involving multiple technologies and design sites.
• Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
• May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.
• May escalate issues to supervisor/manager for resolution, as deemed necessary.
• Mentor other staff as applicable.
• Assist with various projects as assigned by a direct supervisor.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to life and/or move up to 50 lbs. with assistance.
• Bachelor’ s Degree required; Advanced Degree desirable
EXPERIENCE AND REQUIRED SKILLS:
• 5 – 8 years’ related experience; or a Master’ s degree with 3 years’ experience; or a PhD without experience; or equivalent directly related work experience.
• Familiar with software program languages, C, C++, Python and software automatic test systems.
• Understand design history file including risk management, design verification and validation tests and ensuring compliance of these elements to procedural requirements.
• ISTQB Certification or equivalent (nice to have)
• Automatic unit test and continuous integration experience (nice to have)
• Ability to multi-task and operate within a fast-paced environment.