Manager, Software Systems Quality Assurance

Breg Careers • Carlsbad, CA

6h

About The Position

Join Our Team and Keep Moving Forward with Breg! At Breg, we are dedicated to advancing orthopedic solutions that enhance the lives of patients and support healthcare professionals. As a leader in the orthopedic industry, we provide innovative products, consulting, technology, and services that help people move forward with confidence. We are currently seeking Manager, Software Systems Quality Assurance . If you thrive in a dynamic environment where innovation and impact go hand in hand, this is the opportunity for you. Who You Are You are a forward-thinking professional who values collaboration, innovation, and making a meaningful difference. You bring expertise in the ability to communicate effectively both written and verbally and are eager to contribute to a team that is committed to delivering exceptional patient outcomes. What You’ll Do Leads day‑to‑day activities of the Software QA team, providing coaching, guidance, and performance feedback. Leads weekly Software QA staff meetings to review priorities, risks, release readiness, staffing needs, and overall team alignment. Manages on‑shore and off‑shore QA resources, ensuring balanced workloads, clear communication, and efficient operations. Participates in hiring, onboarding, and development of QA staff in partnership with Quality leadership. Drafts, reviews, and evaluates test plans, test scenarios, and scripts, actively identifying gaps in test coverage and ensuring robust validation of software requirements. Oversees the execution of manual and automated testing for software applications across cloud platforms and mobile devices (iPad/iPhone), ensuring thorough test coverage. Participates directly in manual and automated testing activities when needed, such as during critical releases, high‑risk changes, or resource constraints. Reviews test results, identifies trends or potential risks, and recommends alternative testing approaches as needed. Contributes to the evaluation, selection, and adoption of QA tools, methodologies, and automation solutions. Supports the maintenance and continuous improvement of QA practices, standards, methodologies, and metrics in alignment with Development and Quality leadership. Reviews, updates, and maintains standard operating procedures (SOPs) related to software quality to ensure compliance with regulatory requirements and evolving best practices. Prepares, analyzes, and communicates QA metrics, test outcomes, defect trends, and quality risks to technical and non‑technical stakeholders. Provides documentation and support for internal and external audits in partnership with the Quality organization. Reviews change orders related to software modifications to ensure appropriate QA assessment, test planning, risk evaluation, and regulatory alignment. Ensures QA evidence, test documentation, and validation artifacts comply with internal procedures and applicable standards (ISO 13485, FDA QSR, ISO 14971, IEC 62304). May participate in inspections/audits from FDA, ISO, Medicare, and other outside parties as required. Identifies opportunities to improve QA processes, automation, test coverage, and team skill sets. Tracks established Software Quality KPIs, evaluates performance against targets, and communicates trends. Identifies new KPI opportunities and drives action plans to improve product quality, team efficiency, and overall process effectiveness. Supports Quality leadership in implementing continuous improvement initiatives across systems and workflows. Responsible for behaving in a professional manner both internally and externally in relationships that positively impact the company's reputation and comply with the company's policies and practices. Responsible for being accountable and committed to demonstrating Breg’s cultural beliefs and achieving the key results of the company. Responsible for promoting Breg's culture within the organization using established tools such as storytelling, providing focused feedback, and recognition. The performance of the position is aligned with the culture of commitment and accountability, following the steps of: See it, Own it, Solve it, and Do it. Leadership responsibilities include the selection, development, performance management and continuous recalibration of staff; ensures appropriate staffing levels and resource allocation; performs administrative tasks associated with timekeeping, pay, performance, policy administration and other matters related to employment. Assesses staff and provides timely and consistent feedback regarding technical proficiency and effectiveness. Provides constructive feedback, guidance, and reinforcement to employees regarding job performance. Works with staff to identify work goals and create individual development plans. Evaluates training programs to ensure content meets staff needs.

Requirements

• Bachelor’s degree in software engineering or related field of study and 5+ years of professional software QA experience.
• 2+ years in a leadership, supervisory, or team lead role.
• Experience with cloud-based software systems and testing is required.
• Experience testing cloud-based software systems is required.
• Strong proficiency with MS Office and the ability to learn internal systems quickly.

Nice To Haves

• Hands-on experience with software test automation tools is a strong plus, including: Selenium Playwright Record‑and‑playback / low‑code tools such as Cypress, TestComplete, Testim, or equivalent
• Familiarity with CI/CD pipelines, automated testing frameworks, API testing, and defect management tools.
• Working knowledge of ISO 13485, FDA QSR, ISO 14971, or similar regulatory frameworks preferred.
• Experience in medical device, healthcare, or regulated software environments is desirable.
• Experience with Oracle or similar ERP systems preferred.

Responsibilities

• Leads day‑to‑day activities of the Software QA team, providing coaching, guidance, and performance feedback.
• Leads weekly Software QA staff meetings to review priorities, risks, release readiness, staffing needs, and overall team alignment.
• Manages on‑shore and off‑shore QA resources, ensuring balanced workloads, clear communication, and efficient operations.
• Participates in hiring, onboarding, and development of QA staff in partnership with Quality leadership.
• Drafts, reviews, and evaluates test plans, test scenarios, and scripts, actively identifying gaps in test coverage and ensuring robust validation of software requirements.
• Oversees the execution of manual and automated testing for software applications across cloud platforms and mobile devices (iPad/iPhone), ensuring thorough test coverage.
• Participates directly in manual and automated testing activities when needed, such as during critical releases, high‑risk changes, or resource constraints.
• Reviews test results, identifies trends or potential risks, and recommends alternative testing approaches as needed.
• Contributes to the evaluation, selection, and adoption of QA tools, methodologies, and automation solutions.
• Supports the maintenance and continuous improvement of QA practices, standards, methodologies, and metrics in alignment with Development and Quality leadership.
• Reviews, updates, and maintains standard operating procedures (SOPs) related to software quality to ensure compliance with regulatory requirements and evolving best practices.
• Prepares, analyzes, and communicates QA metrics, test outcomes, defect trends, and quality risks to technical and non‑technical stakeholders.
• Provides documentation and support for internal and external audits in partnership with the Quality organization.
• Reviews change orders related to software modifications to ensure appropriate QA assessment, test planning, risk evaluation, and regulatory alignment.
• Ensures QA evidence, test documentation, and validation artifacts comply with internal procedures and applicable standards (ISO 13485, FDA QSR, ISO 14971, IEC 62304).
• May participate in inspections/audits from FDA, ISO, Medicare, and other outside parties as required.
• Identifies opportunities to improve QA processes, automation, test coverage, and team skill sets.
• Tracks established Software Quality KPIs, evaluates performance against targets, and communicates trends.
• Identifies new KPI opportunities and drives action plans to improve product quality, team efficiency, and overall process effectiveness.
• Supports Quality leadership in implementing continuous improvement initiatives across systems and workflows.
• Responsible for behaving in a professional manner both internally and externally in relationships that positively impact the company's reputation and comply with the company's policies and practices.
• Responsible for being accountable and committed to demonstrating Breg’s cultural beliefs and achieving the key results of the company.
• Responsible for promoting Breg's culture within the organization using established tools such as storytelling, providing focused feedback, and recognition.
• The performance of the position is aligned with the culture of commitment and accountability, following the steps of: See it, Own it, Solve it, and Do it.
• Leadership responsibilities include the selection, development, performance management and continuous recalibration of staff; ensures appropriate staffing levels and resource allocation; performs administrative tasks associated with timekeeping, pay, performance, policy administration and other matters related to employment.
• Assesses staff and provides timely and consistent feedback regarding technical proficiency and effectiveness.
• Provides constructive feedback, guidance, and reinforcement to employees regarding job performance.
• Works with staff to identify work goals and create individual development plans.
• Evaluates training programs to ensure content meets staff needs.

Benefits

• Comprehensive Benefits: Medical, dental, vision, disability, and life insurance, effective the first of the month after hire.
• Work-Life Balance: Paid Time Off (PTO) and company-paid holidays.
• Growth & Development: Opportunities for professional advancement within a company that values your contributions.
• Commitment to Diversity & Inclusion: Breg is proud to be an Equal Employment Opportunity employer, fostering a diverse and inclusive workplace.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager