Sequel Med Tech

Manager, Quality

Quality - Manchester, NH - Full Time

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 

The Manager, Quality will lead key elements of the quality system, ensuring compliance with FDA and EU regulations while driving continuous improvement across Sequel’s Quality Management System (QMS). This role has management responsibility for assigned quality system functions, including ownership of performance, strategic leadership, and oversight of quality initiatives.

This role is currently an individual contributor role but may lead a team as the company grows. The Manager, Quality will partner cross-functionally across the business to diagnose and resolve business challenges, analyzing data to determine appropriate solutions while managing complex projects, and integrate quality processes throughout the organization.

Job Responsibilities and Essential Duties 

  • Lead development, implementation, and maintenance of Quality Management System (QMS) elements in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
  • Establish, track, and report on key performance indicators (KPIs) and quality metrics to assess and improve QMS performance.
  • Drive lifecycle management of quality policies, procedures, and documentation, ensuring compliance and continuous improvement.
  • Oversee document and records management for GxP-related documentation, including electronic and paper-based systems.
  • Lead efforts to maintain, improve and optimize QMS processes such as change control, training, CAPA, nonconformance, audit, design control, risk management, production/process controls, and supplier management.
  • Serve as QMS subject matter expert (SME) and lead/support front room and backroom activities for internal audits, regulatory inspections, and third-party audits.
  • Ensure site compliance with good documentation practices (GDP) and cGxP data integrity requirements.
  • Partner with cross-functional teams, including Operations, Engineering, Regulatory, and Manufacturing, to integrate quality systems throughout the product lifecycle and ensure ongoing product quality.
  • Provide onboarding and training on QMS processes and systems to internal stakeholders.
  • Manage and facilitate complex projects related to quality system improvements and compliance initiatives.
  • Own/support management review processes, ensuring leadership engagement in quality performance and compliance.
  • Champion change management initiatives, ensuring smooth adoption of new processes and system enhancements.

Minimum Requirements 

  • Bachelor’s degree in a technical field.
  • 5+ years of experience working in a quality function within a medical device, pharmaceutical, or biotech company.
  • Experience leading and managing a team of quality professionals preferred.

Required Knowledge, Skills and Abilities 

  • Strong expertise in Quality Management Systems (QMS), ISO 13485, FDA 21 CFR Part 820, and risk-based quality principles.
  • Proven ability to analyze complex business challenges, develop data-driven solutions, and lead process improvements.
  • Strong project management and leadership skills, with the ability to manage moderate-risk, complex projects.
  • Self-starter, independently drives projects to completion.
  • Previous experience in a startup environment, or ability to work through ambiguity and pivot quickly when priorities change.
  • Excellent communication and interpersonal skills, with the ability to influence and drive quality initiatives across functions.
  • Ability to work as a change agent, facilitator, mentor, and coach within a fast-paced, growing organization.
  • Quality certifications a plus, e.g. CQE, CQM, CQA.
  • Ability to travel nationwide and internationally, up to 10%.

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 traveling is expected 

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