Quality System Specialist - Post Market & Audit

Merrimack Manufacturing • Manchester, NH

4d • Onsite

About The Position

The Quality System Specialist-Post Market & Audit is responsible for supporting and maintaining the Merrimack Manufacturing Quality Management System (QMS) in compliance with ISO 13485 and applicable regulatory requirements for medical device operations. This role will focus on quality compliance activities including complaint management, internal auditing, regulatory requirement review and alignment, and support of core QMS processes. The position works cross-functionally to ensure quality system effectiveness, regulatory compliance, and continuous improvement initiatives.

Requirements

• Associate degree or equivalent experience in Quality, Engineering, Life Sciences, Manufacturing, or related/applicable field preferred.
• 2–5 years of experience in a Quality Systems or Quality Assurance role within a regulated industry, preferably medical devices.
• Working knowledge of ISO 13485 and global medical device regulatory requirements.
• Experience with complaint handling, internal auditing, and QMS processes preferred.
• Strong understanding of quality system principles and compliance requirements.
• Knowledge of FDA Quality System Regulation (21 CFR Part 820) and other applicable regulations preferred.
• Strong organizational skills and attention to detail.
• Ability to manage multiple priorities and meet deadlines.
• Effective written and verbal communication skills.
• Proficiency with Microsoft Office applications and electronic QMS systems.
• Analytical and problem-solving skills with a continuous improvement mindset.

Nice To Haves

• ISO 13485 Internal Auditor certification preferred.
• ASQ certifications (CQE, CQA, or similar) are a plus.

Responsibilities

• Support the maintenance and continuous improvement of the QMS in accordance with ISO 13485 and applicable global regulatory requirements.
• Ensure QMS procedures, forms, and records remain current, compliant, and aligned with internal processes.
• Assist in preparation and support during external audits, inspections, and certification activities.
• Manage and support the complaint handling process in accordance with internal procedures and regulatory requirements.
• Review complaint records for completeness, accuracy, and timely closure.
• Coordinate investigations and follow-up activities with cross-functional teams.
• Support complaint trending and escalation activities as required.
• Plan, conduct, and document internal quality audits to assess compliance and effectiveness of the QMS.
• Prepare audit reports, identify nonconformities, and track corrective actions through completion.
• Support audit readiness activities across departments.
• Assist in supplier audits or external audit support activities as needed.
• Monitor applicable regulatory standards, guidance documents, and external regulatory changes impacting the business.
• Assess regulatory updates and support alignment of internal procedures and processes with evolving requirements.
• Collaborate with cross-functional teams to implement compliance improvements.
• Contribute to the change control process by reviewing proposed changes for QMS and regulatory impact.
• Support tracking, documentation, implementation, and closure of change activities.
• Ensure appropriate documentation and approvals are maintained.
• Prepare inputs and supporting documentation for Management Review meetings.
• Compile and analyze quality metrics and KPI data, including trends related to complaints, CAPAs, audits, training, and other QMS processes as requested.
• Support generation of reports, dashboards, and presentations for leadership review.
• Assist with document control activities and training compliance support.
• Support CAPA, nonconformance, risk management, and continuous improvement activities as assigned.
• Participate in cross-functional projects supporting quality and compliance objectives.
• Provide administrative and operational support to the QMS team as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree