Director of Operations Quality

About the role

The Director of Operations Quality leads all quality activities across manufacturing and supply‑chain operations, ensuring products meet regulatory and quality system requirements. This senior position provides both strategic direction and hands‑on oversight in a fast‑paced, growth‑oriented environment.

Key responsibilities

• Lead quality activities at manufacturing sites, including incoming inspection, in‑process controls, final release, and batch record review.
• Maintain governance over product release and batch record control, implementing SPC to improve yield and reduce variability.
• Manage, mentor and develop the on‑site operations quality team, recruiting and building a high‑performing organization.
• Approve and control production quality procedures, work instructions and QC sampling plans.
• Manage deviations, non‑conformances, CAPAs and root‑cause investigations, ensuring timely closure.
• Ensure compliance with ISO 13485, MDR/MDD, 21 CFR Part 820 and support internal and external audits.
• Oversee production validations, equipment qualification, process validation and environmental controls.
• Drive supplier quality management, including supplier selection, audits and performance monitoring.
• Control routine sterilization, cleanroom measures and lead quality aspects of facility expansions.
• Develop and report KPIs on product quality, scrap/rework, deviations and CAPA effectiveness to senior leadership.

Required profile

• Degree in life sciences, engineering or related discipline; advanced degree preferred.
• 8+ years of experience in medical device quality, with significant hands‑on manufacturing exposure.

Required skills

• ISO 13485
• MDR/MDD
• 21 CFR Part 820
• Statistical Process Control (SPC)
• Process validation and equipment qualification
• Environmental and cleanroom control
• CAPA management and root‑cause investigation
• Supplier quality management
• Sterilization control
• Batch record review and release governance