Job Description

Key Responsibilities

• Establish, implement, and maintain a comprehensive Quality Management System in alignment with ISO 13485, FDA 21 CFR Part 820, MDSAP, and MDR requirements.
• Ensure compliance with all applicable medical device regulatory standards and customer requirements.
• Develop and document quality processes, policies, and standard operating procedures (SOPs) to support production startup and scale-up.
• Lead the site's efforts to obtain and maintain relevant quality certifications and regulatory approvals.

Product Quality & Compliance

• Oversee all product quality control and quality assurance activities from incoming inspection through final release of finished products.
• Review and approve product releases to ensure full compliance with specifications and regulatory requirements.
• Partner with production, R&D, and engineering teams to implement robust in-process controls and drive defect prevention strategies.
• Lead root cause investigations, CAPA development, and risk management activities to ensure effective and sustainable corrective actions.

Leadership & Team Management

• Build, mentor, and lead a growing team of 6-7 quality professionals.
• Provide training and guidance to ensure adherence to QMS requirements and promote a strong culture of quality and accountability.
• Collaborate closely with cross-functional leaders (Operations, Engineering, Supply Chain, and Regulatory Affairs) to drive quality alignment across the organization.

Customer Feedback & Continuous Improvement

• Establish and maintain a customer feedback and complaint-handling system in accordance with regulatory requirements.
• Collect, analyze, and report post-market surveillance data to identify trends and guide continuous improvement initiatives.
• Conduct regular quality review meetings to assess product performance, customer complaints, and audit findings-developing actionable improvement plans.

Audits & Management Reviews

• Lead internal quality audits and prepare for external audits from regulatory agencies and notified bodies.
• Drive management reviews by providing data-driven insights, key performance indicators (KPIs), and recommendations for system enhancements.

Qualifications

• Bachelor's degree or higher.
• 5+ years of progressive quality management experience in the medical device industry, preferably with Class II or III devices.
• Deep understanding of ISO 13485, FDA 21 CFR 820 (QSR), MDSAP, and MDR quality system requirements.
• Experience with 3D printing/additive manufacturing processes and familiarity with their quality control challenges.
• Proven success in establishing or scaling quality systems in a new or expanding facility is highly preferred.
• Strong leadership, team-building, and organizational skills with the ability to thrive in a fast-paced start-up environment.
• Excellent communication, analytical, and problem-solving skills with a continuous improvement mindset.

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