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Senior Software Quality Engineer – Non-Product Software

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Sequel Med Tech

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Location:
United States , Manchester, NH / Marlborough, MA

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

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Job Description:

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 Responsibility:

  • Support software validation and verification efforts to ensure compliance with FDA regulations and industry standards
  • 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 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
  • Support projects with the IT Engineering team to automate documentation processes
  • 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
  • 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 to support overall non-product software lifecycle management
  • Supports QA department to determine documentation needs
  • Stay up to date with evolving FDA, ISO, and other regulatory requirements for product software quality and validation

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

Nice to have:

  • Project management tracking and trending experience preferred
  • Experience in startup or fast-paced environments is a plus
What we offer:
  • 401k plan with a 6% company match and 100% immediate vesting
  • Capped out-of-pocket insulin costs and GLP-1 coverage across all plans
  • Variety of Meritain health insurance plans
  • Flexible Spending Accounts (FSAs) or Health Savings Account (HSA)
  • Vision and dental coverage
  • Voluntary options such as long-term disability, accident, critical illness, hospital indemnity, and pet care discounts
  • Employer-paid short-term disability and life insurance
  • Flexible PTO
  • Generous paid holidays
  • Flex Time options

Additional Information:

Job Posted:
January 04, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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