The Quality Director reports to the VP QA and is responsible for managing the company’s quality activities at the Bloomington, Minnesota site.

Accountabilities and Associated 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.

Essential 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.

Desirable Requirements:

• Ability to work on-site in Bloomington, MN 4+ days a week.
• Prior experience with returned product analysis and oversight of U.S. FDA 21 CFR Part 806 reporting obligations.

Saluda Medical embraces diversity and equal opportunity in a serious manner. 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. The more inclusive we are, the better our work will be.

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.