Quality Systems Specialist

QRC Group, Inc; Cidra (PR); On-site; USD 90,000 - 140,000; Full time

Job summary

QRC Group, LLC in the United States is seeking a Senior Quality Systems Specialist to support and execute the QMS remediation plan in compliance with ISO 13485, FDA 21 CFR Part 820 (QMSR), and EU MDR 2017/745. You will work with cross-functional teams to ensure documentation accuracy and regulatory alignment.

Responsibilities include executing remediation activities, maintaining SOPs and forms, supporting audits (FDA, Notified Bodies, MDSAP), guiding Change Control and Deviation tasks, and

Qualifications

• BS Science or Engineering required and experience in regulated medical device, pharmaceutical, biotechnology, or life sciences environments.
• Experience writing and revising controlled procedures and supporting Quality Management Systems.
• Experience with Change Control and Deviation Management.

Responsibilities

• Execute and support QMS remediation activities and corrective action plans.
• Ensure Quality System processes comply with regulatory requirements and company policies.
• Develop, review, revise, and maintain controlled quality documentation (SOPs, work instructions, forms, templates).
• Monitor remediation progress and provide timely updates to management.
• Support continuous improvement initiatives to enhance processes and efficiency while maintaining compliance.
• Assist in harmonizing procedures and implementing quality best practices across departments.
• Provide support during audits (Internal, Supplier, Customer, FDA, Notified Body, MDSAP).
• Ensure audit readiness by maintaining documentation and responding to audit observations.
• Assist with Change Requests, Complaint Monitoring, and Deviation Management as needed.

Skills

Regulatory compliance

Documentation writing

Quality systems

Change Control

Deviation Management

Education

BS Science or Engineering

Job 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 aSenior Quality Systems Specialistwho will be responsible for supporting and executing the Quality Management System (QMS) Remediation Plan in compliance withISO 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.

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 ChangeControl,Deviation Management.

Preferred:

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

Additional Information

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