About Sequel
Sequel, headquartered in Manchester, New Hampshire, is a company developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel’s flagship product, the twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type 1 diabetes providing them with personalized diabetes management.
Job Overview
We are looking for an experienced Senior Software Quality Engineer to support the validation of non-product software systems and tools within the quality management system (QMS). This role will ensure compliance with FDA regulations and medical device industry best practices, oversee quality approvals, and support product release. The ideal candidate will be a subject matter expert (SME) in non-product software validation within a highly regulated environment.
Job Responsibilities and Essential Duties
- Support software validation and verification efforts to ensure compliance with FDA regulations and industry standards (e.g., 21 CFR Part 11, IEC 62304, ISO 13485).
- Own the quality approval process for software components, including documentation review and final release approvals.
- Act as the subject matter expert (SME) and work with the software product team to maintain, refine and improve the processes (policies, standard operating procedures (SOPs), and supporting documentation) for this area of the quality system.
- Partner with the software engineering team to implement and maintain a robust software quality management system.
- Establish yourself as a trusted advisor to the Enterprise Applications team, with a problem-solving approach and a willingness to listen to the engineers and ensure the processes and documentation align with current regulations and best practices.
- Support projects with the IT Engineering team to automate documentation processes based on agreed project plans.
- Support the IT and Engineering teams following established service level agreements (SLA’s) and tracking key performance indicators (KPI’s).
- Communicate project and compliance issues to Quality Systems Management and provide solutions to mitigate potential risks
- Develop and support the teams that execute validation protocols, test scripts, and traceability matrices to ensure software functionality, reliability, and regulatory compliance.
- Provide expertise in risk management for software risk assessments.
- Lead internal and external quality audits and investigations related to software validation and compliance.
- Collaborate with cross-functional teams, including regulatory, engineering, and operations, to support overall non-product software lifecycle management.
- Supports QA department to determine documentation needs. Establish and improve necessary document templates and guide staff to support project needs and maintain site compliance with good documentation practices and cGxP data integrity requirements.
- Stay up to date with evolving FDA, ISO, and other regulatory requirements for product software quality and validation.
Minimum Requirements
- Bachelor's degree in life sciences, engineering, or math preferred; or equivalent combination of education and experience.
- 5 + years of quality experience in the pharmaceutical, biotech, or medical device industries.
- 3+ years of experience in non-product software validation within an FDA-regulated environment and experience with releasing software product in multiple regulated geographies.
Required Knowledge, Skills and Abilities
- Project management tracking and trending experience preferred.
- Experience with all aspects of the non-product software validation process in a regulated industry.
- Strong understanding of FDA regulations, ISO 13485, and 21 CFR Part 11.
- Experience with auditor interaction in internal quality audits, regulatory inspections, and nonconformance investigations.
- Experience with agile practices in non-product software validation and lifecycle management.
- Ability to work independently with little oversight; self-starter, action oriented.
- Demonstrated ability to develop and oversee execution of product software validation plans and report generation and other related documentation.
- Excellent communication and leadership skills, with the ability to work cross-functionally.
- Experience in startup or fast-paced environments 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 our benefits package is designed to support you from day one. You’ll be automatically enrolled in our 401k plan, featuring a 6% company match and 100% immediate vesting. We’re committed to your well-being and understand the unique needs of employees and families living with diabetes, so we offer capped out-of-pocket insulin costs and GLP-1 coverage across all plans. You’ll have access to a variety of Meritain health insurance plans to suit your needs and can also take advantage of Flexible Spending Accounts (FSAs) or Health Savings Account (HSA). Our comprehensive benefits package includes vision and dental coverage, plus voluntary options such as long-term disability, accident, critical illness, hospital indemnity, and even discounts for pet care. In addition, we provide employer-paid short-term disability and life insurance for extra peace of mind.
We know the importance of taking time to rest and recharge. That’s why Sequel offers flexible PTO, generous paid holidays, and Flex Time options to help you balance work and life when you need it most. Our team enjoys a culture built on hard work, fun, and genuine support. At Sequel, you’re not just starting a job, you’re building a rewarding career and a brighter future. Join us, and let’s thrive 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
