Senior Manager Quality Digital Product Software

About Sequel
Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.

Job Overview

We are seeking a highly skilled Senior Software Quality Engineer to join our Quality organization. Reporting to the Director of Quality, the Senior Software Quality Engineer will support quality efforts for the development and distribution of software product, including design and development as required and validation and verification efforts for the software components of Sequel’s medical device products. The ideal candidate will have extensive experience in software quality assurance within the medical device industry, ensuring compliance with applicable standards and regulations throughout the software development lifecycle.

Job Responsibilities and Essential Duties

• Provide quality engineering support for software project teams throughout the software lifecycle, from design through launch, ensuring integration of quality into software development, scientific computation, and data acquisition functions.
• Ensure compliance with FDA Quality System Regulation (QSR), ISO 13485, ISO 14971, and IEC 62304 standards.
• Develop and maintain software quality assurance plans, including risk management and validation strategies, to ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams, including software development, regulatory affairs, and clinical teams, to ensure alignment on quality objectives and regulatory expectations.
• Participate in design reviews, code reviews, and other technical assessments to identify potential quality and compliance issues early in the development process.
• Conduct audits and assessments of software development processes and deliverables to ensure adherence to internal procedures and regulatory standards.
• Provide guidance and training to software development teams on best practices for software quality assurance and regulatory compliance.
• Lead the investigation and resolution of software-related quality issues, including root cause analysis and implementation of corrective and preventive actions.
• Stay current with evolving regulatory requirements and industry best practices related to software quality assurance and medical device software development.
• Partner with QA team on software quality documentation.\
• Work closely with the software engineering team to implement and maintain a robust software quality management system.
• Follow agile practices in the development of medical software products, including TIR45, PCCP, or other models for agile software compliance.
• Communicate project and compliance issues to Quality Systems Management and provide solutions to mitigate potential risks

Minimum Requirements

• 5 years' experience in software quality engineering within the medical device industry.

Required Knowledge, Skills and Abilities

• Strong understanding of FDA regulations, ISO 13485, IEC 62304, and 21 CFR Part 11.
• Experience with risk management processes and tools, including FMEA and fault tree analysis.
• Proven ability to work effectively in cross-functional teams and communicate complex quality and regulatory concepts to diverse stakeholders.
• Excellent problem-solving skills and attention to detail, with a proactive approach to identifying and addressing potential quality issues.
• Certification in quality engineering (e.g., ASQ CQE) is a plus.
• Experience in a startup or fast-paced environment is a plus

Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

At Sequel, we believe that when you thrive, we thrive. That’s why we’ve designed a benefits package that’s as thoughtful as it is generous. From day one, you’re automatically enrolled in our 401k plan—no waiting, no worries—with a 6% company match and 100% immediate vesting. We prioritize your well-being, especially for our employees and their families living with diabetes, with capped out-of-pocket insulin costs and GLP-1 coverage across all plans. With multiple medical plans through Aetna, including a 100% company-paid high deductible plan paired with employer HSA contributions, you can select what suits your needs. Additional benefits include vision and dental plans, employer-paid short-term disability, and voluntary options like accident and pet insurance.

Need time to relax and recharge? You’ll enjoy flexible PTO and generous paid holidays, all while being part of a culture that values hard work, fun, and support. We don’t just offer jobs—we offer careers that build futures. Join us, and let’s grow together!

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments May work extended hours during peak business cycles
• Physical requirements such as lifting specific weights
• Some travelling is expected