Associate Director, Quality Assurance

Merck is seeking an experienced quality leader for the role of Associate Director, Quality Assurance, based on-site in Frankfort, Franklin County. In this full-time position, you will provide independent compliance oversight for medical devices and the device components of combination products.

About the Role

Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director, Quality Assurance serves as a trusted compliance partner across Merck's medical device portfolio. This is a hands-on engineering and quality assurance role focused on safeguarding product integrity, supporting regulatory alignment, and championing a culture of continuous improvement for devices and combination products in Frankfort.

Key Responsibilities

• Deliver independent quality engineering and quality assurance support for medical devices, including the device constituent parts of combination products.
• Drive compliance activities that uphold regulatory and quality system requirements throughout the product lifecycle.
• Partner with the Device Quality and Regulatory (DQ&R) organization to address quality challenges and resolve compliance matters.
• Promote and reinforce sound quality practices, standards, and continuous improvement across cross-functional teams.

Qualifications

• Demonstrated background in quality engineering and quality assurance, ideally within medical devices or combination products.
• Working knowledge of applicable device regulations, quality systems, and compliance expectations.
• Ability to operate independently while collaborating effectively with technical and regulatory stakeholders.
• Strong analytical, problem-solving, and communication skills suited to a senior quality leadership role.

About Merck

Merck is a global leader in healthcare innovation, advancing science to improve and save lives around the world. By joining the Device Quality and Regulatory team in Frankfort, Franklin County, you become part of an organization dedicated to delivering safe, high-quality products to the patients and customers who depend on them.

How to Apply

Ready to advance your career as an Associate Director, Quality Assurance with Merck in Frankfort, Franklin County? View the full listing and submit your application here.