Quality Director – Medical Devices & Site Compliance Leader

Saluda Medical; BLOOMINGTON (MN); On-site; USD 150,000 - 210,000; Full time

Job summary

Saluda Medical is seeking a Quality Director to lead quality control and assurance activities at the Bloomington, Minnesota site. You will ensure compliance with global regulatory requirements, manage inspection readiness, and partner with cross‑functional leadership to maintain a strong culture of quality and compliance.

Reporting to the VP of QA, you will direct inspectors, technicians, quality specialists and engineers, drive quality improvement programs, and oversee supplier, distribution,

Qualifications

• 5+ years of medical device quality experience
• 2+ years in leadership
• Experience with post-market, distribution, or supplier quality
• Ability to build relationships with global colleagues
• On-site work 4+ days a week

Responsibilities

• Manage QC activities including receiving inspection and product release.
• Manage QA activities in distribution facility incl. NCRs and supplier quality.
• Ensure global regulatory compliance and Saluda expectations.
• Advocate for strong quality culture with US Distribution and Customer Service.
• Lead inspectors, technicians, quality specialists and engineers.
• Oversee quality challenges across distribution, contract manufacturing and OEMs.
• Develop site inspection readiness and participate in audits.
• Lead quality improvement projects across responsibilities.
• Organize Supplier Change Assessment Board meetings.

Skills

Leadership

Quality systems

Regulatory compliance

Cross-functional collaboration

On-site presence

Education

Bachelor of Science or higher (life sciences or engineering)

Job description

Saluda Medical is seeking a Quality Director to lead quality control and assurance activities at the Bloomington, Minnesota site. You will ensure compliance with global regulatory requirements, manage inspection readiness, and partner with cross‑functional leadership to maintain a strong culture of quality and compliance.

Reporting to the VP of QA, you will direct inspectors, technicians, quality specialists and engineers, drive quality improvement programs, and oversee supplier, distribution,