Postmarket Quality Engineer

About Sequel 

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

Job Overview 

The Quality Engineer will be a key member of our growing Post Market Surveillance team as we build our Quality Management System. The Quality Engineer will primarily support post market surveillance processes, but may provide support across the QMS, including maintaining and improving Quality Management System processes, supporting corrective and preventive actions, quality engineering support for complaint investigations, and field actions, as needed. This is an office-based position in Manchester, NH.

Job Responsibilities and Essential Duties 

• Support the product complaint handling process from intake to closure. 
• Support the collection of follow-up information related to complaints from customers and stakeholders. 
• Work closely with the Customer Care team to ensure timely management of complaint documentation 
• Ensure timely closure of complaints and maintain complete complaint documentation files. 
• Assist with post-market surveillance activities, including planning, data collection, trend analysis, and risk assessments. 
• Collaborate with cross-functional teams to determine root causes and drive corrective and preventive actions (CAPAs). 
• Work closely with cross-functional teams to evaluate field performance and identify areas for product improvements. 
• Ensure compliance with applicable regulations 

Minimum Requirements 

• Bachelor's degree in a technical field preferred (nontechnical degree or equivalent work experience will be considered) 
• 1+ years of experience including quality management, complaint handling, medical device reporting, post market surveillance, or a combination thereof in a commercial-stage medical device, pharmaceutical or biotech company (2+ years preferred) 
• Some knowledge and/or capability to learn US medical device regulations 

Required Knowledge, Skills and Abilities 

• Excellent written and verbal communication skills in English; proficiency in additional languages is a plus 
• Ability to work effectively with cross-functional teams 
• Strong attention to detail, problem-solving, and organizational skills 
• Experience with data analysis or statistical techniques is a plus 
• Ability to manage multiple projects in a fast-paced environment 
• Ability to work independently and as part of a team 
• Basic understanding of medical device regulations 
• Experience with Veeva QMS preferred 
• Basic proficiency in Microsoft Office Suite 
• Ability to work onsite in Sequel’s Manchester, NH office 
• Ability to travel up to 20% 

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