About the Role:

We are seeking a highly experienced and dynamic Director of Quality Engineering to lead our quality assurance and control efforts for our Class III implantable medical devices. In this critical role, you will oversee all aspects of quality engineering, ensuring compliance with stringent regulatory requirements, including FDA QSR, ISO 13485, and other relevant standards.

Key Responsibilities:

• Quality System Leadership: Develop, implement, and maintain a robust quality management system (QMS) aligned with industry best practices and regulatory requirements.
• Oversee the design, development, and implementation of quality engineering processes and procedures, including design controls, process validation, and statistical process control (SPC).
• Ensure compliance with all applicable regulatory requirements, including FDA QSR, ISO 13485, and other relevant standards.
• Lead internal and external audits, including FDA inspections, to identify and address quality issues.
• Develop and implement a robust corrective and preventive action (CAPA) program to address quality issues and prevent recurrence.
• Product Quality: Drive continuous improvement initiatives to enhance product quality and reliability.
• Lead failure investigations, root cause analysis, and corrective action implementation.
• Collaborate with cross-functional teams to ensure product designs and manufacturing processes meet quality standards.
• Monitor and analyze key quality metrics to identify trends and opportunities for improvement.
• Team Leadership: Lead and mentor a team of quality engineers to foster a culture of quality excellence.
• Recruit, hire, and develop a high-performing quality engineering team.
• Provide technical guidance and support to engineering and operations teams.
• Foster a collaborative and results-oriented work environment.

Qualifications:

• Advanced degree in engineering or a related field.
• Minimum of 10 years of experience in quality engineering within the medical device industry, with a strong focus on Class III implantable devices.
• In-depth knowledge of FDA QSR, ISO 13485, and other relevant regulatory requirements.
• Proven track record of leading and managing quality engineering teams.
• Strong technical expertise in design controls, process validation, and statistical process control.
• Excellent problem-solving, analytical, and decision-making skills.
• Strong communication and interpersonal skills, with the ability to effectively interact with cross-functional teams.
• Experience with risk management, including FMEA and risk analysis.
• Experience with quality system implementation and maintenance.