Restoring Compliance Coverage at a Medical Device Manufacturer Mid-Transition

The client is a Class II medical device manufacturer located in Rochester, New York, that develops clinically validated blood pressure monitoring technology deployed across pharmacy chains, physician practices and health systems across the United States and Canada. The organization is governed by an ISO 13485- and MDSAP-certified quality management system. In a lean, specialist organization, compliance sits at the center of every commercial relationship and regulatory obligation the business has.

At the time of this service engagement, the company was midway through a transition from an in-house to a contract manufacturing model. The move required a recalibration of all its quality systems, supplier oversight, and documentation frameworks across the business.

Two members of the regulatory and quality team departed quickly, one after another, leaving a compliance function previously occupied by two dedicated roles with no coverage at all. The leadership decided to consolidate the scope of the role and that the position could be handled by a single specialist under the new contract manufacturing model. But the new role had a higher bar: full ownership of the quality management system, audit readiness, CAPA and nonconformance management, change control, supplier documentation, and maintaining ISO 13485 and MDSAP status. All of it. Independently. 

The combination of depth and self-direction is a specialist credential. Medical device QMS (Quality Management System) experience at this level of ownership is usually concentrated in certain regulated environments and seldom surfaces in usual postings. In a fifteen-person organization with no tolerance for a long learning curve, the search required the Keller team to find somebody who was already operating at that standard. 

Keller conducted a targeted search in the medical device industry and other related regulated hardware environments. The profile, someone working at the intersection of regulatory affairs and quality systems, in a lean, certified environment, is not found on public job boards. The search was based on direct engagement with specialists in similar regulated environments, with shortlisted candidates providing video introductions for the client to assess technical depth and working style prior to the investment of interview time.

Keller found and placed a Regulatory Affairs Specialist with hands-on experience in QMS ownership, audit management, CAPA processes, and documentation compliance in a regulated device environment. The appointed specialist had also previously built and maintained quality systems in lean, ISO-certified organizations and fully understood the full suite of responsibilities the role required from day one. The search was completed, effectively closing the compliance gap that had been widening since the departure of the two team members.