Quality Engineer

Mancheser, NH
Full Time
Quality
Mid Level

About Sequel 

Sequel Med Tech is an emerging medical device company committed to revolutionizing patient care through innovative solutions. Our mission is to improve the lives of patients by developing cutting-edge medical technologies that address unmet needs in healthcare. 

Job Overview 

The Quality Engineer will be a key member of our growing Quality/Regulatory team as we build our Quality Management System. The Quality Engineer will provide support across the QMS which may include responsibility for maintaining and improving the Quality Management System processes, control of documents and training materials, and quality engineering support for product development, and supplier management.  This is an office-based position in Manchester, NH.

Job Responsibilities and Essential Duties 

Quality Management System Process 

  • Assist with internal and external audits including logistics and planning 
  • Coordinate/track/drive closure of QMS audit report responses. Ensure closure and verification of implementation in a timely manner 
  • Support the Nonconformance (NCMR) process including containment, correction, closure, and drive continuous improvement through analysis of trend data 
  • Support the Corrective and Preventive Action (CAPA) process. Ensure closure and verification of implementation in a timely manner 
  • Support the generation and reporting of metrics as inputs into Management Review and Quality Metric review presentations 
  • Support the supplier management processes including qualification, maintenance, and SCARs 
  • Support product development, risk management activities, and distribution of product (including software and demo devices)  
  • Support quality planning and change development activities including assessing impact, verification of deliverables and driving plans to closure 

Document and Training Materials Control 

  • Assist with activities related to controlled documents, promotional materials, labelling, translation, printed materials, external standards and training materials in the quality management system including creation, routing, approval tracking, change controls, and obsolescence 
  • Assist with activities related to training assignments, training completion metrics, and impact assessments 
  • Review documents and materials for accuracy, completeness, and compliance in accordance with relevant regulations (e.g., ISO 13485, FDA 21 CFR 820) 
  • Work cross functionally to ensure compliance with regulatory requirements, internal policies, and industry standards 

Minimum Requirements 

  • Bachelor's degree in a technical field preferred (nontechnical degree or equivalent work experience will be considered) 
  • 1+ years of experience working within quality management, document control, regulatory affairs, manufacturing, or a combination thereof in a commercial-stage medical device, pharmaceutical or biotech company. 
  • Experience leading projects and driving to completion 

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 
  • 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 Vault, Veeva QMS, Veeva PromoMats 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!  

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