Quality Director

About the role

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, delivers known, consistent, and personalized spinal cord stimulation therapy by objectively measuring neural responses and maintaining therapy within a prescribed therapeutic window. Headquartered in Minneapolis, Minnesota, the Quality Director reports to the VP QA and is responsible for managing the company’s quality activities at the Bloomington, Minnesota site. At Saluda, we challenge boundaries, innovate beyond the conventional, and aim to revolutionize the standard of care in neuromodulation to positively impact patients’ lives. Our core values are People – our first responsibility is to the patients we serve; Integrity – do the right thing; Pioneering – lead boldly, change lives, disrupt the status‑quo; Performance – win together – deliver with excellence.

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 in 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 requests have the required information for the Change Assessment Board.

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

Skills

• 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