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Sequel Med Tech · 1 day ago

Senior Software Quality Engineer – Non-Product Software

Manchester, NH

Full-time

Onsite

Senior Level

5+ years exp

Sequel Med Tech, headquartered in Manchester, New Hampshire, is focused on developing transformative drug-delivery advancements for diabetes management. They are seeking an experienced Senior Software Quality Engineer to support the validation of non-product software systems and ensure compliance with FDA regulations and industry best practices.

Health CareInformation TechnologyMedical

H1B Sponsor Likely

Responsibilities

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

Qualification

Non-product software validationFDA regulations complianceISO 13485 knowledgeQuality management systemAgile practicesInternal quality auditsProject management experienceCommunicationLeadership skillsCross-functional collaboration

Required

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

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

Preferred

Bachelor's degree in life sciences, engineering, or math preferred; or equivalent combination of education and experience

Project management tracking and trending experience preferred

Experience in startup or fast-paced environments is a plus

Benefits

401k plan, featuring a 6% company match and 100% immediate vesting

Capped out-of-pocket insulin costs

GLP-1 coverage across all plans

Variety of Meritain health insurance plans

Flexible Spending Accounts (FSAs)

Health Savings Account (HSA)

Vision and dental coverage

Voluntary options such as long-term disability, accident, critical illness, hospital indemnity, and even discounts for pet care

Employer-paid short-term disability and life insurance

Flexible PTO

Generous paid holidays

Flex Time options

Company

Sequel Med Tech

We’re Sequel — a driven team of innovators and problem solvers laser-focused on improving the health and lives of people with diabetes.

Founded in 2023

Manchester, New Hampshire, USA

201-500 employees

https://sequelmedtech.com

H1B Sponsorship

Sequel Med Tech has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2024 (1)