Quality Director

Job Description

Job Description

Salary : POSITION SUMMARY

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.

SUPERVISORY RESPONSIBILITIES

This position will supervise the Quality Assurance Manager.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Leadership & Strategy

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.

Quality Management System (QMS)

Oversee and maintain the QMS to ensure compliance with ISO 9001 : 2015 and ISO

13485 : 2016.

Manage document control, change control, CAPA, internal audits, non-conformance

reporting, and risk management processes.

Ensure alignment of Quality Management Systems with applicable regulatory requirements

e.g., FDA)

Audits & Inspections

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.

Supplier Quality

Establish and maintain supplier quality management programs.

Conduct supplier audits and monitor supplier performance metrics.

Training & Development

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.

QUALIFICATIONS

Bachelors degree in engineering, Life Sciences, Quality Management, or related field

Masters preferred).

Minimum of 810 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.

PHYSICAL DEMANDS

While performing the duties of this job the employee is regularly required to remain in an office at a computer workstation and access information from a computer. The employee is required to be mobile to, from, and within the office. The employee may occasionally move up to 25 pounds.

WORK ENVIORMENT AND EXPECTATIONS

• Draper Utah Office-based position with fully onsite.

LifeWave 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 at LifeWave. If 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.