The Quality Associate is responsible for the day-to-day execution, maintenance, and continuous improvement of the company’s Quality Management System (QMS), ensuring alignment with applicable regulatory standards including ISO 13485, MDSAP, FDA, and MDR. This role plays a vital part in maintaining product quality through incoming, in-process, and final inspections, while also supporting document and records control processes, change management, and internal audits.

This role supports cross-functional teams by ensuring documentation integrity, regulatory compliance, and effective resolution of quality issues.

Key Responsibilities:

· Quality Management System Administration

o Assist in the daily implementation and maintenance of the QMS under the supervision of the Quality Manager.

o Monitor compliance with internal procedures and regulatory requirements.

o Support preparation for internal and external audits (e.g., MDSAP & MDR).

· Document & Records Control

o Manage the lifecycle of controlled documents: creation, review, approval, issuance, revision, and archival in compliance with Document Control procedures.

o Maintain records such as: Training records, Environmental monitoring, Supplier documentation, Standards library & Device history records (DHRs)

o Manage electronic data capture (EDC) process for the clinical trial, ensuring that data is submitted accurately, completely, and in a timely manner, in accordance with protocol requirements.

· Production Quality Activities

o Perform incoming inspection of raw materials, components, and subassemblies for both production and R&D.

o Conduct in-process and final inspections to ensure conformance to product specifications and manufacturing requirements.

o Issue and close work orders in alignment with production schedules and quality records.

· Change Controls, Non-conformance & CAPA

o Manage Change Control activities ensuring proper documentation and implementation.

o Manage the Non-Conforming Product process, ensuring timely segregation, investigation, and documentation.

o Support Corrective and Preventive Action (CAPA) investigations to identify root causes, implement corrective actions, and verify effectiveness.

· Auditing & Supplier

o Participate in and conduct internal audits in accordance with the audit schedule.

o Assist in supplier qualification and re-evaluation processes, maintaining accurate records of approved vendors and their performance.

· Customer Feedback

o Administer the Product Feedback process, ensuring all customer complaints, feedback, and adverse events are recorded, investigated, and addressed promptly and effectively.

Skills:

· Strong attention to detail and accuracy.

· Organized, methodical, and capable of managing multiple priorities.

· Excellent verbal and written communication skills.

· Confident in identifying and escalating non-compliance with procedures.

· Ability to collaborate effectively across departments.

· Proficiency in Microsoft 365 and familiarity with document control software or QMS platforms.

Education and Experience:

· 1–5 years of experience in a quality or document control role, preferably within the medical device industries.

· Working knowledge of ISO 13485, MDSAP, FDA, and MDR is strongly preferred.

· Internal Auditor certification (ISO 13485 or equivalent) is an advantage.

· Experience with electronic document control systems is desirable.