Quality Engineer: Own Validation & Compliance

Life Science Outsourcing; Somersworth (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

Life Science Outsourcing, Inc. is seeking a Quality Engineer to own the Quality Engineering function at the Somersworth, NH site. You will validate processes, manage CAPA, risk assessments, and supplier quality, and serve as the technical voice during audits.

You will partner with Operations, Manufacturing Engineering, and customers' quality teams to ensure ISO 13485 and FDA 21 CFR Part 820 compliance, while driving continuous improvement and ensuring product release confidence.

Qualifications

• BS or MS in engineering or a scientific discipline.
• 3+ years manufacturing medical devices (Class I/II).
• Knowledge of ISO 13485, FDA 21 CFR Part 820, GMP, ISO 14971.
• Experience with FMEAs or risk assessment activities.
• Ability to read engineering drawings with GD&T.

Responsibilities

• Own the Quality Engineering function for the site and ensure products meet requirements before release.
• Write verification/validation protocols (IQ, OQ, PQ) and analyze data.
• Drive CAPA issuance, investigations, and effectiveness verification.
• Lead supplier quality audits, SCARs, and customer quality interactions.
• Support regulatory audits and QMS administration.

Skills

Quality engineering

Statistical analysis

Minitab

Root cause analysis

Process validation

ISO 13485

Auditing

Education

BS or MS in engineering or scientific discipline

Tools

Minitab

Job description

Life Science Outsourcing, Inc. is seeking a Quality Engineer to own the Quality Engineering function at the Somersworth, NH site. You will validate processes, manage CAPA, risk assessments, and supplier quality, and serve as the technical voice during audits.

You will partner with Operations, Manufacturing Engineering, and customers' quality teams to ensure ISO 13485 and FDA 21 CFR Part 820 compliance, while driving continuous improvement and ensuring product release confidence.