Quality Systems Specialist

QRC; Cidra (PR); On-site; USD 90,000 - 135,000; Full time

Job summary

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

The role involves leading remediation activities, supporting audits (FDA, Notified Bodies, MDSAP), and driving process improvements while maintaining compliance across departments.

Qualifications

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

Responsibilities

• Execute and support QMS remediation activities and corrective actions.
• Ensure QMS processes meet regulatory requirements and company policies.
• Develop, review, and maintain SOPs, work instructions, forms, and templates.
• Monitor remediation progress and report to management.
• Support continuous improvement while maintaining compliance.
• Assist harmonizing procedures across departments.
• Support audits (internal, supplier, customer, FDA, Notified Body, MDSAP).
• Maintain audit readiness and respond to observations.
• Assist Change Requests, Complaint Monitoring, and Deviation Management.

Skills

Quality Systems

QMS remediation

Audits support

Change Control

Deviation Management

Documentation

Education

BS Science or Engineering.

Job description

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Job Description

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.i
• Assist with Change Requests (CRs), Complaint Monitoring, and Deviation Management activities as needed.

Qualifications

• 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.

Additional Information

All your information will be kept confidential according to EEO guidelines.