Lead Quality Engineer, Medical Devices (On-Site)

Life Science Outsourcing Inc; Somersworth (NH); On-site; USD 85,000 - 120,000; Full time

Job summary

Life Science Outsourcing, Inc. (LSO) is seeking an experienced Quality Engineer for our Somersworth, NH site. The role focuses on establishing robust quality processes for Class I and II medical devices, including validation, risk management, CAPA, and supplier quality.

You will act as the technical voice during audits and drive continuous improvement across QMS processes, ensuring compliance with ISO 13485 and FDA 21 CFR Part 820. This is a hands-on, on-site position at the LSO East NH site.

Qualifications

• BS or MS in engineering or a scientific discipline.
• Three or more years manufacturing medical devices or disposables (Class I and Class II).
• Working knowledge of ISO 13485, FDA 21 CFR Part 820, GMP, and ISO 14971.
• Hands-on experience with design control, process validation, failure investigation, and root cause analysis.
• Experience participating in FMEAs or other risk assessment activities.
• Ability to read and interpret engineering drawings with GD&T interpretation, procedure manuals, and operating instructions.
• Intermediate Minitab capability and confident applied statistics.
• Microbiology, sterilization, and cleanroom manufacturing experience preferred. Lean and Six Sigma knowledge a plus, Green Belt preferred.

Responsibilities

• Validate and qualify processes (IQ, OQ, PQ) and develop verification/validation reports.
• Lead risk management activities including PFMEA and risk assessments.
• Drive CAPA issuance, investigations, and verification of effectiveness.
• Manage supplier and customer quality activities, audits, and SCARs.
• Support regulatory audits (FDA/ISO) and respond to findings.
• Contribute to new product and process introductions and quality planning.

Skills

Root cause analysis

Regulatory awareness

Auditing readiness

Cross-functional collaboration

Education

BS or MS in engineering or a scientific discipline

Tools

Minitab

FMEA/Risk assessment methods

Job description

Life Science Outsourcing, Inc. (LSO) is seeking an experienced Quality Engineer for our Somersworth, NH site. The role focuses on establishing robust quality processes for Class I and II medical devices, including validation, risk management, CAPA, and supplier quality.

You will act as the technical voice during audits and drive continuous improvement across QMS processes, ensuring compliance with ISO 13485 and FDA 21 CFR Part 820. This is a hands-on, on-site position at the LSO East NH site.