Senior Quality Systems Specialist – QMS Remediation

About the role

We are looking for a Senior Quality Systems Specialist to lead the execution of our Quality Management System (QMS) remediation plan. You will work closely with cross‑functional teams to ensure our documentation, processes, and audits meet ISO 13485, FDA 21 CFR Part 820, EU MDR, and other regulatory requirements.

Key responsibilities

• Execute and support QMS remediation activities and corrective action plans.
• Develop, review, and maintain controlled quality documents such as SOPs, work instructions, forms, and templates.
• Monitor remediation progress, report updates to management, and support continuous‑improvement initiatives.
• Assist with change requests, complaint monitoring, and deviation management.
• Provide support during internal, supplier, customer, FDA, Notified Body, and MDSAP audits.

Required profile

• Bachelor’s degree in Science or Engineering.
• 5‑10 years of experience in a regulated medical device, pharmaceutical, biotechnology, or life‑sciences environment.
• Proven experience writing and revising controlled procedures and supporting QMS.
• Experience with change control and deviation management.

Required skills

• ISO 13485 implementation and maintenance.
• FDA 21 CFR Part 820 (QMSR) compliance.
• EU MDR 2017/745 knowledge.
• QMS remediation project experience.
• SOP and controlled document development.
• Change control and deviation management processes.