Senior Software Quality Engineer – Non-Product Software

Role Overview

• 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.

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.

Benefits

• 401k plan featuring a 6% company match and 100% immediate vesting.
• Capped out-of-pocket insulin costs and GLP-1 coverage across all plans.
• 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 discounts for pet care.
• Employer-paid short-term disability and life insurance.
• Flexible PTO, generous paid holidays, and Flex Time options.