Senior Quality Systems Consultant

Job Duties

• Provides hands-on quality systems support at a medical device manufacturing site, addressing daily quality issues and supporting production teams.
• Leads investigations into nonconformances, deviations, complaints, and audit findings using 8D, 5 Why, and Fishbone analysis.
• Manages CAPA activities from investigation through implementation and effectiveness verification.
• Drives remediation of quality issues and audit findings, ensuring actions are assigned, tracked, and completed on time.
• Reviews quality procedures, work instructions, and records to identify compliance gaps and improvement opportunities.
• Supports internal and external audits, audit responses, and regulatory compliance.
• Assists with eQMS implementation and process improvements, including CAPA, complaint handling, document control, and training.
• Collaborates with U.S. and international quality teams to align processes and resolve quality issues.
• Provides weekly status reports, tracks open actions, escalates risks, and coaches personnel on quality processes and problem-solving.

Requirements

• Minimum of 8 years of quality systems experience in medical device manufacturing or a similarly regulated industry.
• Proven experience with CAPA, root-cause analysis, nonconformances, complaints, and audit remediation.
• Working knowledge of ISO 13485 and FDA Quality Management System Regulation (QMSR) requirements.
• Experience working with manufacturing, engineering, operations, and quality teams.
• Strong problem-solving, project coordination, communication, and documentation skills.
• eQMS implementation, internal auditing, and multi-site quality experience preferred.
• Bachelor’s degree in engineering, science, quality, or a related field preferred; equivalent experience considered.

Term & Start

• On-site in Dudley, Massachusetts, approximately 3 days per week, with remote support as needed.
• Interim consulting contract; 25-35 hours/week.
• Start as soon as possible following approval and onboarding.
• Candidates should be within a reasonable commuting distance of the site.