Quality Director

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.

What You’ll Bring

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.

Our Core Values

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. Saluda Medical embraces diversity and equal opportunity. We are committed to building a team representative of a variety of backgrounds, perspectives and skills. We believe people are the source of our inspiration and innovation. Saluda Medical does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Saluda Medical’s approved agency list. Unsolicited resumes or candidate information submitted to Saluda Medical by search/recruiting agencies not already on Saluda Medical’s approved agency list shall become the property of Saluda Medical.