Jobs in New Hampshire 2026 (Now Hiring) - Smart Auto Apply

• 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.

• 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.

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

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