Senior Quality Engineer

Laborie Medical Technologies Corp.; Portsmouth (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

Laborie Medical Technologies is seeking a Senior Quality Engineer in Portsmouth, NH. The role ensures compliance with regulations in medical devices and involves mentoring junior team members while driving strategic quality initiatives. Candidates should possess extensive experience in quality assurance within the medical field.

Benefits

Paid time off

Paid volunteer time

Medical, Dental, and Vision

401k with Company Match

Parental Leave and Adoption Services

Health and Wellness Programs

Qualifications

• 8+ years in medical device quality/compliance, or 6 years with Master's.
• Experience developing software requirements and test case packages.
• Proven ability to write clear and concise reports.

Responsibilities

• Create and review software and system requirements.
• Lead corrective/preventive action initiatives.
• Collaborate in Bug Triage including root cause analysis.

Skills

Leadership

Project Management

Conflict Resolution

Agile Project Management

Education

Bachelor’s in engineering or related scientific field

Master’s degree in engineering or related field

Tools

Matrix

DOORs

Cognition Cockpit

Job description

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 in software development to join our team on-site 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 lifecycle. 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 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.

• Paid time off and paid volunteer time
• Medical, Dental, Vision and Flexible Spending Account
• Health Savings Account with Company Funded Contributions
• 401k Retirement Plan with Company Match
• Parental Leave and Adoption Services
• Health and Wellness Programs and Events

Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.