Manager, Software Quality Assurance

Position Location: Alameda, CA

The Opportunity

This Manager, Software Quality Assurance is responsible for providing assurance that product software and computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements.

• Provide Quality leadership in direct support of implementation and maintenance of the Software System Lifecycle Processes for both product and non-product software
• Management and development of Quality Engineers, Specialists, and/or other staff on the Software Quality Assurance Team.
• Participate as a member of the project team for Lingo products that incorporate software/firmware into their system.
• Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of the software or firmware.
• Provide guidance on Software Quality Assurance processes, procedures and best practices to ensure implementation in accordance with regulatory requirements.
• Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic, and international quality regulations and applicable quality certification requirements
• Provide influential peer leadership with partner sites to drive proactive quality improvements.
• Identify Quality Initiatives and lead cross-functional teams to complete them.
• Provide proactive, diligent, and fact-based communication to Sr. Management, peers, and team.
• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
• Lead, oversee or contribute to multiple portions of the Quality System, including Design controls, software design transfer, software maintenance, change control, defect management, non-product software validation, and risk management.
• Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.
• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
• Support and or implement all Divisional quality validation initiatives as needed/required.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

• Bachelor’s Degree, preferably in Engineering, Technical Field, Life Science, or closely related discipline.
• 8+ years’ experience in a Software Quality Assurance experience in a medical device company
• 3+ years’ experience leading a team of technical and/or quality professionals.
• Knowledge of FDA QSR, relevant ISO guidelines, IEC62304 and 21 CFR Part 11.

• Prior experience in a medical device company with mobile application software (iOS, Android) highly preferred
• Knowledge of Jira, Confluence, ALM Quality Center, and/or other software development and test tools is a plus.
• ASQ Certifications a plus.

The base pay for this position is $109,300.00 – $218,500.00. In specific locations, the pay range may vary from the range posted.