Quality Assurance Engineer

About the Role

BioBoston Consulting is supporting a medical device client in Salem, NH with an urgent need for a Quality Assurance Engineer.

This is a full-time, onsite role for someone who can step in quickly and support day-to-day quality operations during a transition period.

The ideal candidate has hands-on medical device quality experience and is comfortable working with batch records, CAPAs, NCRs, validation documentation, training, and quality system documentation.

Key Responsibilities

• Review batch records and related manufacturing documentation
• Support CAPA investigations, follow-up, and closure
• Support NCR / nonconformance investigations and documentation
• Review validation protocols, reports, and supporting documentation
• Review and update quality system documentation, including SOPs and forms
• Support training documentation and training compliance
• Work cross-functionally with QA, Manufacturing, Engineering, and Operations
• Help maintain compliance with FDA and ISO requirements
• Support audit readiness and quality system improvements as needed

Required Qualifications

• 5–10 years of Quality Systems, Quality Engineering, or Quality Assurance experience
• Medical device industry experience required
• Experience with FDA 21 CFR 820 and ISO 13485
• Hands-on experience with CAPA, NCRs, deviations, investigations, and documentation review
• Experience reviewing batch records and/or device history records
• Experience with validation protocols and reports
• Strong technical writing and documentation skills
• Ability to work full-time onsite in Salem, NH
• Strong communication and cross-functional collaboration skills

Preferred Qualifications

• Experience in IVD, diagnostics, or regulated manufacturing environments
• Experience with eQMS systems such as MasterControl, Veeva, TrackWise, Greenlight Guru, or similar
• Experience supporting audits or inspection readiness