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Hot Job – Director of Quality (Regulatory and Quality Leadership)

A director of quality works with others in an organization to establish quality control methods and standards, as well as track performance against these methods and standards.

In the medical device industry, this position more specifically involves overseeing a group of quality engineers focused on the manufacture of medical devices, which includes concentrating on production and process controls, equipment, electrical systems and software systems.

A director of quality is usually accountable for establishing in-house quality techniques, standards and metrics founded on regulatory and customer specifications. In addition to addressing quality matters for finished products, this position calls for the establishment of quality standards for raw materials and suppliers.

A director of quality must also ensure the staff receives proper quality training. This person must work with leadership and staff to determine operational procedures, standards and systems. A director of quality must also ascertain training needs and oversee the creation of a training program for quality control.

A quality director also has a significant amount of administrative responsibilities. They must evaluate statistical data to create managerial and technical reports, occasionally with an eye toward serving as a driver for improvement. This position involves setting objectives to optimize profitability and tracking performance in the direction of established targets.

Job Requirements

Employers typically prefer that a quality director has a bachelor’s degree, preferably in mechanical or electrical engineering – although a master’s degree is ideal. Applicants for these positions should also be an ASQ-certified quality engineer with a Six Sigma certification. In order to be successful, a quality director ought to have a solid understanding of medical device guidelines.

A quality director should have a minimum of 10 years of engineering experience, preferably with capital equipment and process validation. They should also have a minimum of five years of experience with medical devices. A quality director needs to have a strong understanding of production and process controls in an FDA-regulated environment, in addition to a good understanding of risk management.

To work in the medical device industry, a quality director must have knowledge of quality test techniques and standards specifically for medical devices. They ought to have experience in test-plan development and root-cause analysis for the investigation of various quality issues.

In addition to having technical expertise, a quality director must be a strong supervisor who can coach and develop the people around them. This normally calls for strong verbal and written communication abilities particularly with regard to technical material.

Often, a quality director is a highly educated individual who set out on a management track early on in their career, but occasionally a production worker with many years of experience can jump into the role after taking management classes.

Career Outlook

A director of quality control in the medical device industry typically enjoys a base salary of between $150,000 and $175,000 with a fifteen percent bonus, as well as significant opportunities for growth and advancement.

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