Quality Director

Saluda Medical Pty; BLOOMINGTON (MN); On-site; USD 140,000 - 210,000; Full time

Job summary

Saluda Medical seeks a Quality Director to lead site quality initiatives at our Bloomington, Minnesota facility. You will manage QC/QA activities, supplier and distribution quality, and ensure compliance with global regulatory requirements, including FDA 21 CFR Part 806.

You will build strong cross-functional partnerships with Supply Chain, Regulatory Affairs, Clinical, and Engineering, mentor inspectors and engineers, and drive site inspection readiness and quality improvement.

Qualifications

• Manage QC/QA activities at the Bloomington site and distribution facility.
• Ensure compliance with global regulatory requirements and Saluda expectations.
• Lead inspectors, technicians and engineers with inclusive leadership.
• Oversee supplier quality and OEM-related quality challenges as they arise.
• Coordinate internal and external audits to ensure quality system effectiveness.

Responsibilities

• Lead QC/QA at site including receiving inspection and product release.
• Oversee distribution facility QA, NCRs, and supplier quality.
• Ensure regulatory compliance and alignment with Saluda business goals.
• Foster a culture of quality with cross-functional leadership.

Skills

Leadership

Quality systems

Post-market quality

Distribution quality

Supplier quality

Regulatory affairs

Cross-functional collaboration

On-site work

FDA CFR 806

Education

Bachelor of Science in life sciences or engineering

Job description

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.

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

What You’ll Do:

• 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.