Quality Systems Specialist

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.

Responsibilities

• 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.