Quality Engineer

At Life Science Outsourcing (LSO), the products leaving our floor are surgical kits, single-use devices, and sterile disposables that clinicians open in front of a patient. Our Somersworth, New Hampshire site, known for years as J-Pac Medical, builds Class I and Class II devices under ISO 13485 and FDA 21 CFR Part 820. As Quality Engineer, you are the person who proves those processes are sound before product is ever released.

This is a single-owner role, not a seat in a large quality department. You will run validation, risk management, CAPA, and supplier quality for the site, reporting directly to the Director of Quality & Regulatory Affairs. If you want your judgment to carry weight rather than route through three layers of review, and you are comfortable being the technical voice in the room when an auditor asks a hard question, this is built for you.

What You'll Do

You will own the Quality Engineering function at LSO East, partnering daily with Operations, Manufacturing Engineering, and our customers' quality teams.

Validation & Process Qualification

• Write protocols, analyze data, and generate summary reports for verification and validation activities (IQ, OQ, PQ).
• Create and implement methods for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Apply statistics with real rigor: sample size selection, Cpk analysis, Gage R&R, and tolerance analysis.

Risk Management & Design Control

• Generate and maintain PFMEA and risk assessment files in line with ISO 14971.
• Participate in Material Review Board and risk management reviews, confirming corrective measures meet reliability standards.
• Interpret and assess conformity to regulatory standards across engineering and manufacturing.

CAPA & Investigations

• Drive CAPA issuance, investigation, implementation, and closure through to verification of effectiveness.
• Apply structured root cause methodology and implement corrective action you can actually measure.
• Investigate and provide objective evidence concerning customer requirements and complaints.

Supplier & Customer Quality

• Conduct supplier evaluation, qualification, quality audits, and supplier corrective actions (SCARs).
• Serve as the customer-facing quality engineering contact for assigned programs.
• Support FDA, ISO 13485, and customer audits, including preparing for and responding to findings.

New Product & Process Introduction

• Participate in product quality planning for new products, equipment, and processes.
• Manage multi-phase development projects from inception through planning, prototyping, and evaluation.
• Act as co-administrator for the electronic QMS and support document control activities.
• Serve as technical support between Product Development, Business Development, Manufacturing Engineering, and Operations.

Qualifications: What You Bring

Skills & Experience

• 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.

Mindset & Impact

• You take ownership of a function rather than waiting for the next assignment.
• You are precise under time pressure, because in this industry the documentation is part of the product.
• You can explain a validation decision to an auditor, a customer, and an operator on the floor, and be understood by all three.
• You look for the root cause rather than the fastest closure.
• You want visibility into the whole operation, not one narrow slice of it.

Work Environment

• On-site at our Somersworth, New Hampshire facility, part of Life Science Outsourcing since 2023.
• ISO 13485 certified and FDA registered medical device contract manufacturing environment.
• Cleanroom gowning required when entering controlled production areas.
• Regular time on the production floor as well as at a desk. This is not a remote quality role.
• Must be physically able to sit or stand for extended periods.
• Must have the ability to walk extended distances as needed.
• Clarity of vision at 20 inches or more, with the ability to view a computer monitor for extended periods.