Quality Director

Saluda Medical•Minneapolis, MN

4d•Onsite

About The Position

Saluda Medical is a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed-loop neuromodulation platform. The company’s proprietary technology senses and measures neural responses to stimulation and automatically adjusts therapy based on real-time neurophysiological feedback. Saluda Medical’s first product, the Evoke® System, is designed to deliver known, consistent, and personalized spinal cord stimulation therapy by objectively measuring neural responses and maintaining therapy within a prescribed therapeutic window. Saluda Medical is headquartered in Minneapolis, Minnesota. At Saluda, we challenge boundaries. We innovate and think beyond the conventional. Our focus is to revolutionize the standard of care in neuromodulation to positively impact patient’s lives.

Requirements

Bachelor of Science degree or higher in a life sciences or engineering discipline
At least 5+ years of experience in medical device quality with 2+ years of leadership experience.
Proven ability to execute and maintain quality systems, with direct experience in post-market quality, distribution quality, or supplier quality.
Strong relationship builder and communicator with diverse work teams
Experience building strong relationships with global colleagues.
Ability to work on-site 4+ days a week.
Prior experience with returned product analysis and oversight of U.S. FDA 21 CFR Part 806 reporting obligations.

Responsibilities

Manage all quality control (QC) activities, to include receiving inspection and product release from the site.
Manage all quality assurance activities in the distribution facility, to include non-conformance reports (NCR) and supplier quality for our contract manufactured and OEM acquired products.
Ensure activities performed in the facility are compliant to global regulatory requirements for which we claim compliance, as well as Saluda business expectations.
In partnership with the head of US Distribution and Customer Service, be a vocal advocate for a strong culture of quality and compliance at the site.
Build strong working relationships with other cross-functional leadership at the site to include Supply Chain, Distribution & Customer Service, Clinical, Sustaining Engineering, and Regulatory Affairs.
In partnership with the head of US Distribution and Customer Service, ensure products distributed from the facility are handled appropriately and distributed to customers accurately and in a timely manner.
Provide direct leadership to inspectors, technicians, quality specialists and engineers utilizing an inclusive and empowering leadership approach.
Manage distribution, contract manufacturing and OEM-related quality challenges as they arise.
Develop and ensure the implementation of a site inspection readiness plan.
Participate internal and external audits to ensure the site’s quality system is effective.
Manage and lead quality improvement projects in all areas of responsibility.
Organize Supplier Change Assessment Board meetings and ensure submitted change request has the required information for the Change Assessment Board.