Senior Director, Quality Operations

We are seeking a dynamic and experienced leader to oversee global manufacturing quality operations for a medical device organization. This role will focus on ensuring the production and supply of high-quality devices and components that meet regulatory standards and customer expectations.

As the Senior Director, Quality, you will drive excellence in quality systems, supplier quality, and manufacturing processes across global sites. You will lead a team dedicated to fostering a culture of quality and operational efficiency.

Key Responsibilities

Leadership:

• Build, mentor, and lead a high-performing global quality team.
• Foster innovation and continuous improvement in supply chain and manufacturing processes.
• Drive team engagement to ensure consistent delivery of high-quality results.

Operations:

• Ensure manufacturing and supplier operations comply with regulatory standards (e.g., ISO13485, 21 CFR Part 820).
• Optimize processes to reduce cost of poor quality and improve supply chain efficiency.
• Lead validation activities for new lines, processes, and product transfers.
• Collaborate with R&D and engineering teams to develop robust validation strategies.

QMS:

• Oversee the implementation and maintenance of site Quality Management Systems (QMS).
• Conduct trend analysis and drive actions to reduce non-conformance events.
• Harmonize quality processes across sites to align with corporate standards.

Compliance and Analytics:

• Ensure adherence to global regulatory requirements.
• Prepare for and lead external audits, including FDA and ISO inspections.
• Establish robust supplier management and auditing programs.
• Develop and report metrics and key performance indicators to inform decision-making.

Qualifications

Education:

• Bachelor’s degree in Engineering or a related technical field (e.g., Industrial, Mechanical).
• Advanced degree preferred.

Experience:

• 9+ years of quality assurance experience in a manufacturing environment, with a focus on medical devices or similar regulated industries.
• 6+ years of people management experience, including leadership of senior and mid-level managers.
• Experience in supplier quality management and working with contract manufacturers.
• Proven ability to lead geographically dispersed teams across multiple sites.

Skills:

• In-depth knowledge of quality regulations (e.g., ISO 13485, ISO 14971, QSR).
• Expertise in risk management, process validation, and quality system implementation.
• Strong leadership and communication skills with a track record of motivating teams.
• Proficiency in data analysis and trending to drive quality improvements.