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Staff Software Quality Engineer in San Francisco Bay Area at APEX Systems

Date Posted: 6/14/2019

Job Snapshot

Job Description

Job #:  970168
Our client is a leader in the pharmaceutical and medical device industry. They are one of the most recognized international companies in the world and they are seeking top notch talent to join their team.

JOB DESCRIPTION:


The Staff Software Quality Engineer is responsible for supporting product development of mechanical circulatory support systems for patients with heart failure.  Products include pumping systems, electronic controllers, power sources, and other devices for temporary and long-term management of heart failure.  The Staff Software Quality Engineer position focuses primarily on software quality, but also supports other aspects of product development based on experience. 
The Staff Software Quality Engineer position:
  • Provides technical and quality system guidance related to establishing software requirements.
  • Supports software verification and validation activities for new products in accordance with design planning procedures.  This includes, but is not limited to, review and approval of software test case protocols and reports, review of software development plans, and review of other system and software documentation.
  • Leads meetings to prioritize, review and/or approve of action plans for addressing issues captured in problem resolution systems during development.
  • Performs risk evaluation and associated management activities related to software development including FMEA, product risk analysis, and mitigation of software issues. 
  • Participates in technical and management reviews to ensure design plans, product design and deliverables related to product software are met.  Represent the quality engineering function for the review and approval of designated design outputs.   
  • Supports non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required. 
  • May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team
  • Drive best practices for establishing requirements and completing design verification and validation especially as it relates to user needs.
  • Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures. 
  • Maintains a strong, collaborative partnership with cross functional team members especially with R&D.
  • Works as an individual contributor and may provide guidance or oversee work of other QE team members.

Basic Qualifications:
  • Bachelor level degree in Engineering or Technical Field;
  • 8+ years of software engineering experience
  • Previous quality engineering experience and demonstrated use of quality tools/methodologies 

Preferred Qualifications:
  • Experience working in a broader enterprise/cross-division business unit model preferred
  •  advanced degree preferred
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. 

 
 
 
 
 
 
 
 
EEO Employer
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.