Quality Systems Specialist

We are seeking a Quality Systems Specialist who will support the execution and maintenance of 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 Quality Systems Specialist will collaborate with cross-functional teams to support documentation accuracy, regulatory compliance, and the implementation and maintenance of quality system requirements.

Responsibilities

• Support the execution of QMS remediation 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.
• 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.
• 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 (QMS).
• Familiarity with Change Control and Deviation Management processes.
• Strong organizational skills and attention to detail.
• Effective written and verbal communication skills.

Preferred Qualifications

• 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.