Quality System Specialist - Post Market & Audit
On-site · Manchester, New Hampshire, United States
Job Summary
Quality System Specialist - Post Market & Audit to support and maintain the QMS (ISO 13485) for Merrimack Manufacturing. Focus on complaint management, internal audits, regulatory requirement reviews and alignment, and support of core QMS processes. Works cross-functionally to ensure quality system effectiveness, regulatory compliance, and continuous improvement. Responsibilities include maintaining QMS procedures and records, preparing for external audits and certifications, managing complaint handling, conducting internal audits, tracking CAPAs, assisting in supplier/audit activities, monitoring regulatory changes, supporting change control, generating quality metrics and reports, and providing training/document control support. Qualifications include an Associate degree or equivalent, 2–5 years in a regulated QA/QMS role in medical devices, knowledge of 21 CFR Part 820, and ISO 13485; preferred ISO 13485 Internal Auditor and ASQ CQE/CQA certifications.
Required Qualifications
- Associate degree or equivalent experience preferred in Quality, Engineering, Life Sciences, Manufacturing, or related field
- 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
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.