Sr. Quality Systems Specialist

QRC Group; Cidra (PR); On-site; USD 95,000 - 125,000; Full time

Job summary

QRC Group in Puerto Rico seeks a Senior Quality Systems Specialist to support and execute the QMS remediation plan in compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR. You will work with cross-functional teams to ensure documentation accuracy, regulatory compliance, and effective maintenance of quality system requirements.

The role involves remediation execution, documentation development, and supporting audits (Internal, Supplier, Customer, FDA, Notified Body, and MDSAP).

Qualifications

• BS in science or engineering.
• 5–10 years of experience in a regulated medical device or life sciences environment.
• Experience writing and revising controlled procedures.
• Experience supporting Quality Management Systems.
• Experience with Change Control and Deviation Management.

Responsibilities

• Execute and support remediation activities within the QMS.
• Ensure QMS processes comply with regulatory requirements and company policies.
• Develop, review, and maintain controlled documentation (SOPs, Work Instructions, forms).
• Monitor remediation progress and report to management.
• Support audits by internal, supplier, customer, FDA, Notified Body, and MDSAP teams.
• Maintain audit readiness and assist in responses to findings.
• Assist with Change Requests and Deviation Management.

Skills

Quality management systems

Regulatory compliance

Audit readiness

Change control

Deviation management

Education

BS in Science or Engineering

Job description

Cidra, Puerto Rico | Posted on 08/19/2026

We are seeking a Senior Quality Systems Specialist who will be responsible for supporting and executing the Quality Management System (QMS) Remediation Plan in compliance with ISO 13485, FDA 21 CFR Part 820 (QMSR), EU MDR 2017/745 , applicable regulatory requirements, and company procedures.

The Senior Quality Systems Specialist works closely with cross-functional teams to ensure documentation accuracy, regulatory compliance, and the effective implementation and maintenance of quality system requirements.

• Execute and support QMS remediation activities and corrective action plans.
• Ensure Quality System processes comply with applicable regulatory requirements, company policies, and industry standards.
• Develop, review, revise, and maintain controlled quality documentation, including SOPs, Work Instructions, Forms, and Templates.
• Monitor remediation progress and provide timely updates to management.
• Support continuous improvement initiatives by identifying opportunities to enhance processes and increase efficiency while maintaining compliance.
• Assist in harmonizing procedures and implementing quality best practices across departments.
• Provide support during Internal, Supplier, Customer, FDA, Notified Body, and MDSAP audits.
• Ensure audit readiness by maintaining accurate documentation and supporting responses to audit observations and findings.
• Assist with Change Requests (CRs), Complaint Monitoring, and Deviation Management activities as needed.
  

Requirements

• BS Science or Engineering.
• 5-10 years of experience in a regulated medical device, pharmaceutical, biotechnology, or life sciences environment.
• Experience writing and revising controlled procedures.
• Experience supporting Quality Management Systems.
• Experience with Change Control, Deviation Management.

Preferred:

• Experience with QMS remediation projects.
• Experience implementing ISO 13485 Quality Systems.