Director of Quality

Overview

This position requires a strategic, experienced, and detail-oriented Quality Director to lead our Quality Management System (QMS) and ensure compliance with ISO 9001 and ISO 13485 standards. The Quality Director will oversee the development, implementation, and continuous improvement of quality policies, procedures, and systems across all areas of the business. This role is critical in maintaining product integrity, customer satisfaction, and regulatory compliance within a medical device environment.

• Lead and manage the Quality Assurance and Quality Control teams.
• Define quality objectives and drive a culture of continuous improvement.
• Act as the Management Representative for ISO certifications and audits.
• Oversee and maintain the QMS to ensure compliance with ISO 9001:2015 and ISO 13485:2016, reporting, and risk management processes.
• Ensure alignment of Quality Management Systems with applicable regulatory requirements (e.g., FDA).
• Plan and lead internal and external audits, including third-party certification and regulatory inspections.
• Respond to audit findings and ensure timely implementation of corrective actions.
• Establish and maintain supplier quality management programs.
• Conduct supplier audits and monitor supplier performance metrics.
• Collaborate with the training department to develop and deliver quality training programs across the business unit.
• Ensure employees are trained and compliant with relevant quality procedures.

• Bachelor’s degree in engineering, Life Sciences, Quality Management, or related field (Master’s preferred).
• Minimum of 8–10 years of experience in quality assurance/control in a regulated industry (medical device, pharmaceutical, or manufacturing).
• Strong expertise in ISO 9001 and ISO 13485 standards.
• Knowledge in the cosmetic industry preferable but not essential.
• Proven experience managing audits and maintaining quality certifications.
• Strong leadership, communication, and project management skills.

Life Wave will operate as an in-office organization, and all employees are required to work onsite in alignment with corporate policy. While performing the duties of this job, the employee is regularly required to work at a computer workstation and be mobile within the office. Occasional movement of up to 25 pounds may be required.

Life Wave is committed to creating an inclusive workplace that values diversity and promotes equal opportunities for all. We embrace the principles of the Americans with Disabilities Act (ADA) and strive to provide reasonable accommodations to qualified individuals with disabilities.

In our pursuit of building a diverse and talented team, we encourage candidates of all abilities to apply for positions  you require accommodation during the application or interview process, please inform our HR department, and we will work with you to ensure your needs are met.