Join a leading Medical Device Company as a Director of Quality to be responsible for leading the Quality Management system in compliance with ISO 13485, 21 CFR Part 820, MDSAP and other applicable regulatory requirements. This role oversees quality across the product lifecycle, including design control, operations, and post-market activities.
Key Responsibilities:
Lead implementation and oversight of design control processes for new and modified devices.
Manage and ensure quality in operations: production, final product release, incoming inspection activities, process validation and supplier quality.
Manage configuration and doc control process.
Own and maintain the quality management system, including internal audits, CAPA, complaints, and management review.
Prepare for and lead external audits (e.g. notified bodies, FDA).
Requirements: Bachelors degree in engineering, life sciences, or a related field (Masters preferred).
Minimum 10 years of experience in quality roles within the medical device industry.
Strong knowledge of ISO 13485, 21 CFR Part 820, and MDSAP requirements.
Proven leadership and team management experience.
Experience with quality in Operations.
Experience with internal/external audits and regulatory inspections. Certified lead auditor.
Experience in design control process.
Excellent problem-solving, communication, and cross-functional collaboration skills.
Fluent in English Hebrew
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