Quality Director, MedTech | Lead Compliance & Inspections

Regulatory Jobs; BLOOMINGTON (MN); Presencial; USD 140.000 - 210.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Leadership

Quality systems

Post-market quality

Distribution quality

Supplier quality

Regulatory affairs

Cross-functional collaboration

On-site work

FDA CFR 806

Educación

Bachelor of Science in life sciences or engineering

Descripción del empleo

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.