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.
Skills Required
- Bachelor of Science degree in 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 and Deviation Management
- Experience with QMS remediation projects
- Experience implementing ISO 13485 Quality Systems
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
