Software Quality Assurance Senior Manager

Software Quality Assurance Senior Manager

Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

At Nova Biomedical, we're not just building instruments, we're powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.

Our integration brings together more than 70 years of scientific excellence with Nova's cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we're setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.

With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we're building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.

Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you'll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health.

About the Role

The Software Quality Assurance Senior Manager leads the software quality organization responsible for ensuring the safety, reliability, and regulatory compliance of software used in medical device systems. This role oversees verification and validation activities across embedded firmware and cloud-based applications, ensuring compliance with IEC 62304 and related regulatory standards. The position bridges engineering, regulatory, and business teams to deliver audit-ready software solutions used in clinical environments. The Senior Manager drives continuous improvement through automation, modern tooling, and AI-enabled quality practices.

If you're passionate about SQA and want to be part of a team that is shaping the future of life sciences, we'd love to hear from you, apply today!

What You'll Do

• Lead the development and execution of software verification and validation (V&V) strategies to ensure compliance with IEC 62304, ISO 13485, FDA 21 CFR Part 11, and IVDR requirements.
• Oversee software testing activities across embedded diagnostic hardware, firmware, and cloud-hosted applications that process and store patient data.
• Ensure end-to-end traceability between software requirements, risks, test cases, and defects using ALM and issue-tracking tools such as Jama Connect and Jira.
• Drive modernization of software quality practices by transitioning from manual-heavy testing approaches to automation-first strategies.
• Pilot and implement AI-assisted tools to support test plan development, edge-case generation, and predictive defect analysis.
• Manage, mentor, and develop Software Development Engineers in Test (SDETs) and QA Engineers, fostering a proactive and accountable quality culture.
• Communicate software quality risks, test results, and regulatory readiness to engineering leadership and cross-functional stakeholders.
• Perform other duties as assigned.

What We Are Looking For In You

• Minimum of 10 years of experience in Software Quality Assurance, including at least 7 years in a leadership or management role within the medical device, healthcare, or similarly regulated industry.
• Deep expertise in IEC 62304, ISO 13485, FDA 21 CFR Part 11, and IVDR regulatory requirements.
• Demonstrated experience testing embedded systems, cloud-based applications, and hybrid edge-to-cloud architectures.
• Proven ability to design, implement, and maintain automated test frameworks for embedded firmware and web-based APIs.
• Experience operating within regulated CI/CD environments such as Jenkins, GitLab, or Azure DevOps.
• Strong analytical, problem-solving, and communication skills, with the ability to translate technical and regulatory risks into business-relevant terms.
• Solid understanding of cybersecurity principles and cybersecurity testing practices.
• Bachelor's degree in Computer Science, Biomedical Engineering, or a related technical field required.
• Master's degree preferred or an equivalent combination of education and professional experience.

Physical Requirements For This Role Include:

• Ability to work at a computer for extended periods.
• Ability to lift and carry up to [25–50] pounds as required
• Ability to communicate effectively via phone, video, and written communication.
• Ability to occasionally move about the office to access meetings or resources.

Why Work For Nova Biomedical

• Flexible Medical, Dental, & Vision Coverage
• Competitive 401k company match
• Bonus Program, Generous PTO and paid holidays
• Generous Tuition reimbursement
• Hybrid and flexible work arrangements
• Professional development, engagement and events
• Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
• Company subsidized cafeteria in our Waltham, MA office

Work Location: Onsite in Waltham, General Business Hours

Targeted Salary Range: $170,000 - $210,000/year.

Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.

EEO Statement:

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.