The Role
Supports QMS remediation, corrective actions, controlled documentation, regulatory compliance, audit readiness, change requests, complaint monitoring, and deviation management. Collaborates cross-functionally to harmonize procedures, improve quality processes, track remediation progress, and support internal, supplier, customer, FDA, notified body, and MDSAP audits in a regulated life sciences environment.
Summary Generated by Built In
We are seeking a Quality Systems Specialist will collaborate with cross-functional teams to support documentation accuracy, regulatory compliance, and the implementation and maintenance of quality system requirements.
- Support the execution of QMS activities and corrective action plans.
- Assist in ensuring Quality System processes comply with applicable regulatory requirements, company policies, and industry standards.
- Draft, review, revise, and maintain controlled quality documentation, including SOPs, Work Instructions, Forms, and Templates.
- Support track remediation activities and provide status updates to Quality Management.
- Participate in continuous improvement initiatives by identifying opportunities to enhance processes and maintain compliance.
- Support the harmonization of procedures and implementation of quality best practices across departments.
- Assist during Internal, Supplier, Customer, FDA, Notified Body, and MDSAP audits.
- Help maintain audit readiness through accurate documentation and timely follow-up of audit observations and findings.
- Support Change Requests (CRs), Complaint Monitoring, and Deviation Management activities as needed.
- Perform other quality-related duties as assigned.
Requirements
- Bachelor's degree in Science, Engineering, or a related technical discipline.
- 2-3 years of experience in a regulated medical device, pharmaceutical, biotechnology, or life sciences environment.
- Experience writing, revising, and maintaining controlled procedures and quality system documentation.
- Experience supporting Quality Management Systems (QMS).
- Familiarity with Change Control and Deviation Management processes.
- Strong organizational skills and attention to detail.
- Effective written and verbal communication skills.
Skills Required
- Bachelor’s degree in Science, Engineering, or a related technical discipline
- 3-5 years of experience in a regulated medical device, pharmaceutical, biotechnology, or life sciences environment
- Experience writing, revising, and maintaining controlled procedures and quality system documentation
- Experience supporting Quality Management Systems
- Familiarity with Change Control and Deviation Management processes
- Strong organizational skills and attention to detail
- Effective written and verbal communication skills
- Experience supporting QMS remediation or quality improvement projects
- Experience working within an ISO 13485-compliant environment
- Familiarity with FDA Quality System Regulations and applicable international standards
- Experience participating in internal or external audits
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The Company
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.
