Senior Quality Assurance Manager

Overview

We're working with a small medical device company looking to add a Senior Quality Manager to their team due to a promotion. This position will play a key leadership role in maintaining compliance, driving continuous improvement, and ensuring the highest standards of product quality and patient safety.

Key Responsibilities

• Lead and manage the site Quality team, including Quality Engineering, Quality Assurance, and Quality Control functions.
• Oversee all quality activities related to manufacturing, including process validation, nonconformance management, CAPA, and change control.
• Ensure compliance with ISO 13485, FDA QSR, and other applicable regulatory standards.
• Partner closely with Manufacturing, Engineering, and Supply Chain to support production and new product introductions.
• Drive continuous improvement initiatives focused on yield, efficiency, and quality performance.
• Prepare for and lead internal and external audits and inspections.
• Develop and implement site quality strategies aligned with corporate objectives.

Qualifications