Jobs and Careers

Senior Quality Engineer

Portsmouth, United Statesfull_timeVerifiedPosted 26 Mar 2025

About the role

We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you. We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion. Who We’re Looking For: Laborie Medical Technologies is currently searching for a Senior Quality Engineer strong in software development to join our team in the Portsmouth, NH office. The Senior Quality Engineer serves as a site or product-specific subject matter expert (SME) and mentor for junior team members. This role ensures that the technical regulatory and quality requirements are met both within the Quality Management System and throughout the product life cycle. Additionally, the Senior Quality Engineer drives strategic quality initiatives and ensures compliance with high standards. How you contribute:

Create and review software and system requirements in a requirements database system. Map software requirements to test cases and associated FMEA failure modes.
Develop and execute product and process monitoring and measurement activities.
Design, develop, and review software, verification/validation protocols, test case packages, and perform related experimentation as needed.
Lead or collaborate in lead root cause analysis activities on test failures.
Investigate proposed process/product changes to ensure continued safety and compliance with QSR and ISO requirements in the medical device industry.
Lead corrective and preventive action initiatives, utilizing statistical techniques to identify and resolve potential quality issues.
Collaborate in Bug Triage including root cause analysis, risk assessment, hazard evaluation, correction, and corrective action.
Provide leadership and mentorship to the Quality Engineering team, supporting design/development activities and managing regulatory projects with external agencies and test labs.

Minimum Qualifications:

Minimum 8 years of experience in technical medical device quality and compliance roles (or 6 years with a Master’s degree) and a Bachelor’s (or Master’s) in engineering or a related scientific field.
Strong experience in developing and reviewing software requirements and test case packages in a requirements database system (e.g., Matix, DOORs, Cognition Cockpit) and working knowledge of Agile Project Management.
Experience in software development for medical devices.
Proven ability to write clear, concise reports and procedures, with minimal supervision and the ability to quickly learn with guidance.
Knowledge of Quality System Regulation (CFR 820), ISO standards, Risk Management (ISO 14971), and experience with quality audits.
Strong leadership, project management, organizational, communication, and conflict resolution skills.

Preferred Qualifications:

Lean Six Sigma certification
ASQ certification.
Lead auditor certification in quality audits.

Why Laborie:Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.