Quality Engineer

LIFE SCIENCE OUTSOURCING INC•Somersworth, NH

48d•Onsite

About The Position

Life Science Outsourcing (LSO) is seeking a Quality Engineer for its Somersworth, New Hampshire site, formerly J-Pac Medical. This site specializes in building Class I and Class II medical devices, including surgical kits, single-use devices, and sterile disposables, operating under ISO 13485 and FDA 21 CFR Part 820. The Quality Engineer will be responsible for ensuring the soundness of manufacturing processes before product release. This is a key individual contributor role, reporting directly to the Director of Quality & Regulatory Affairs, where the engineer will own the Quality Engineering function for the site, including validation, risk management, CAPA, and supplier quality. The role requires technical expertise and the ability to make impactful decisions.

Requirements

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.
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.

Nice To Haves

Microbiology, sterilization, and cleanroom manufacturing experience preferred.
Lean and Six Sigma knowledge a plus, Green Belt preferred.

Responsibilities

Own the Quality Engineering function at LSO East, partnering daily with Operations, Manufacturing Engineering, and customer quality teams.
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.
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.
Drive CAPA issuance, investigation, implementation, and closure through to verification of effectiveness.
Apply structured root cause methodology and implement corrective action that can be measured.
Investigate and provide objective evidence concerning customer requirements and complaints.
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.
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.