Senior Quality Systems Specialist

Location: Monroe, NC
Employment Type: Full-Time, On-Site
Salary Range: $55,000 - $83,000/year + Bonus

Position Summary

A growing medical device manufacturer is seeking a Senior Quality Systems Specialist to oversee and improve key elements of the Quality Management System (QMS). This role focuses on change control, CAPA, eQMS administration, document control, and compliance, ensuring alignment with ISO 13485, ISO 9001, and FDA QSR standards.

The position partners closely with manufacturing, engineering, regulatory, and operations teams to drive quality system effectiveness, support audits, and strengthen overall compliance across the site.

Key Responsibilities

Quality Systems Management

• Ensure the QMS meets regulatory requirements including ISO 13485, ISO 9001, and 21 CFR 820.
• Identify system gaps and lead continuous improvement initiatives across quality processes.
• Support internal and external audits, providing documentation, metrics, and follow-up on findings.

Electronic Quality Management System (eQMS)

• Administer the electronic document control system (eQMS), ensuring accuracy, accessibility, and version control.
• Coordinate document reviews, approvals, retirements, and controlled distribution.
• Train users on eQMS workflows, documentation requirements, and system updates.

Change Control

• Lead and facilitate the full lifecycle of change control requests, including initiation, risk assessment, impact evaluation, approvals, implementation, and post-change verification.
• Support and/or lead Change Control Board (CCB) activities.
• Maintain traceability and compliance for product, process, and documentation changes.

Corrective & Preventive Actions (CAPA)

• Oversee CAPA investigations, ensuring robust root cause analysis and sustainable corrective actions.
• Conduct and review effectiveness checks to confirm long-term closure.
• Drive CAPA timeliness and maintain KPI dashboards for management review.

Nonconformance & Deviation Management

• Lead NCR investigations involving cross-functional teams (manufacturing, QC, engineering, supply chain).
• Apply structured problem‑solving tools including 5 Why's, fishbone diagrams, and fault-tree analysis.
• Analyze NCR trends and recommend process improvements to prevent recurrence.

Training, Compliance & Documentation

• Develop and update SOPs, work instructions, templates, and training materials.
• Support employee training on QMS elements, CAPA, change control, and compliance expectations.
• Ensure documentation, records, and investigations meet internal and regulatory standards.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or a related technical field.
• 3+ years of experience in Quality Systems within a regulated environment (medical device or pharmaceuticals preferred).
• Strong knowledge of FDA QSR, ISO 13485, ISO 9001, and cGMP requirements.
• Experience administering or working extensively within an eQMS platform.
• Hands-on experience with change control, CAPA, NCRs, and document control.
• Strong analytical, documentation, and root‑cause investigation skills.
• Excellent communication and cross-functional collaboration abilities.

Additional Requirements

• Ability to work fully on-site at the Monroe, NC manufacturing facility.
• Comfortable interacting with operations, engineering, regulatory, and quality teams.
• Strong attention to detail and ability to manage multiple ongoing QMS elements simultaneously.
• Proficiency with Microsoft Office and quality system tools (eQMS, ERP, or related platforms).

What This Role Offers

• An opportunity to lead key QMS processes at a high‑growth medical device organization
• A collaborative environment with visibility across engineering, manufacturing, and leadership
• Opportunities for professional development in change control, CAPA leadership, and audit readiness
• Competitive compensation with bonus eligibility and potential relocation support