Job Description

Will oversee and continuously improve Quality Management System (QMS) in compliance with ISO 13485 and other applicable regulatory standards. Ensures product quality, process efficiency, and operational compliance across all manufacturing functions.

The ideal candidate is a hands-on leader with a strong background in medical device quality systems, process controls, and continuous improvement methodologies.

Key Responsibilities

• Lead, manage, and develop the QA team to maintain compliance with ISO 13485 and FDA 21 CFR Part 820.
• Oversee daily quality control processes, ensuring all operations meet regulatory and customer requirements.
• Maintain and enhance the site’s Quality Management System (QMS), including CAPA, Nonconformance, and Change Control systems.
• Monitor production and process controls to ensure consistency and traceability of critical processes.
• Develop and update quality procedures, work instructions, and process documentation.
• Coordinate and support internal, customer, and third-party audits; ensure timely closure of audit findings.
• Drive continuous improvement projects focused on reducing defects and improving product reliability.
• Train and mentor personnel on QMS requirements, documentation practices, and regulatory compliance.
• Prepare and present quality metrics and performance reports to leadership.

Qualifications

• Education: Bachelor’s degree in Engineering, Quality Management, Life Sciences, or a related technical field.
• Experience: Minimum 3+ years in a quality control or process management role within a medical device or regulated manufacturing environment.
• In-depth understanding of ISO 13485, 21 CFR Part 820, and risk management (ISO 14971).
• Proven experience maintaining and improving QMS documentation and processes.
• Strong command of data analysis tools and Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
• Knowledge of process validation, root cause analysis, CAPA, and statistical techniques.
• Familiarity with electronic QMS or document control systems is a plus.

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