Sr. Quality Systems Specialist

QRC Group, LLC; Cidra (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

QRC Group, LLC in Cidra, Puerto Rico seeks a Senior Quality Systems Specialist to drive and support QMS remediation in line with ISO 13485, FDA 21 CFR Part 820, and EU MDR 2017/745. You will collaborate with cross-functional teams to ensure documentation accuracy and regulatory compliance while maintaining and improving the quality system.

The role includes supporting audits, change controls, deviation management, and continuous improvement initiatives to enhance processes and efficiency in a

Qualifications

• Regulatory compliance knowledge across medical devices and pharma in regulated environments.
• Ability to develop, review, and maintain controlled documentation and SOPs.

Responsibilities

• Execute and support QMS remediation activities and corrective action plans.
• Ensure Quality System processes comply with regulatory requirements, company policies, and standards.
• Develop, review, revise, and maintain SOPs, work instructions, forms, and templates.
• Monitor remediation progress and provide updates to management.
• Assist during audits (internal, supplier, customer, FDA, Notified Body, MDSAP).
• Support Change Requests, deviation management, and complaint monitoring.

Skills

Regulatory compliance

Documentation accuracy

Cross-functional collaboration

Audit readiness

Education

BS in Science or Engineering

Tools

QMS experience

Change Control

Deviation Management

Job description

Cidra, Puerto Rico

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.