CAPA & Quality Systems Specialist

Merrimack Manufacturing; Manchester (NH); On-site; USD 80,000 - 110,000; Full time

Job summary

Merrimack Manufacturing is seeking a Quality System Specialist – CAPA to support and maintain the QMS in compliance with ISO 13485 and FDA QSR. The role focuses on coordinating CAPA, NC, change control, and QMS improvements across functions.

This position requires strong root cause analysis, documentation discipline, and cross-functional collaboration to investigate and close quality events effectively. Familiarity with regulatory requirements and internal audits is essential.

Qualifications

• 2–5 years of experience in Quality Systems, Quality Assurance, or regulated industry (medical device preferred).
• Direct experience in CAPA coordination, investigations, or quality systems strongly preferred.
• Working knowledge of ISO 13485 and FDA QSR (21 CFR Part 820).
• Associate or Bachelor's degree in Quality, Engineering, Life Sciences, or a related field preferred.

Responsibilities

• Coordinate CAPA processes within the QMS to ensure ISO 13485 and FDA QSR compliance.
• Maintain CAPA logs, ensure timeliness and completeness of records.
• Monitor CAPA due dates and escalate overdue/high-risk items.
• Execute CAPA activities from investigation to corrective actions; verify effectiveness.
• Support root cause analyses (e.g., 5-Why, Fishbone) and document findings.
• Assist in NC and change control activities; support audits and QA initiatives.
• Prepare KPIs, dashboards, and trend reports for management review.

Skills

CAPA lifecycle

Root cause analysis

Cross-functional collaboration

Attention to detail

Documentation

Analytical skills

MS Office

Verbal communication

Education

Associate or Bachelor's degree in Quality/Engineering/Life Sciences

Tools

Electronic QMS systems

Microsoft Office

Job description

Merrimack Manufacturing is seeking a Quality System Specialist – CAPA to support and maintain the QMS in compliance with ISO 13485 and FDA QSR. The role focuses on coordinating CAPA, NC, change control, and QMS improvements across functions.

This position requires strong root cause analysis, documentation discipline, and cross-functional collaboration to investigate and close quality events effectively. Familiarity with regulatory requirements and internal audits is essential.