Senior Quality & Regulatory Leader, Global Medical Devices

Vantive; Plymouth (MN); Presencial; USD 144.000 - 198.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) retirement plan

Paid holidays

Disability and life insurance

Descripción de la vacante

Vantive seeks a Quality Management Representative (QMR) for its Twin Cities R&D multi-site campus. You will implement the Vantive Global Quality Management System and manage QMS documents for Quality, R&D, Regulatory, Facilities, across multiple sites.

You will lead PRRC, oversee VIP/MDDAP activities, train staff, manage NCR/CAPA and coordinate external inspections to ensure regulatory compliance and product quality.

Formación

• Bachelor-level engineering or science degree required.
• 8+ years in Quality/Manufacturing/Engineering with 3–4 years supervisory experience.
• Knowledge of global regulatory and quality requirements for medical devices; ISO 13485, FDA 21 CFR parts 7/11/803/806/810/820, ISO 14971, MDD 93/42/EEC, EU MDR 2017/745.
• Proven leadership of large global teams; strong verbal and written communication.
• Experience with multifunctional global teams and third-party development partners.
• Excellent problem solving, negotiation and influencing skills.

Responsabilidades

• Quality Lead for PRRC responsibilities for legal manufacturing at Vantive Twin Cities sites.
• Oversee participation in FDA VIP via MDDAP program using CMMI.
• Lead and train multi-site personnel; ensure NCR/CAPA ownership and Trackwise access.
• Manage legal manufacturing quality responsibilities across sites and external manufacturers.
• Lead periodic management reviews to ensure QMS effectiveness.
• Ensure regulatory conformance for QMS activities and manufacturing oversight.
• Coordinate external regulatory inspections and audits as lead interface.
• Support MDDAP process as CMMI Practitioner/Professional.
• Oversee NCR/CAPA processes and internal quality assessments.
• Drive continuous improvement projects for quality, reliability and cost.
• Budget development and cross-location budget adherence.
• Coach and develop subordinates; manage quality budgets across sites.

Conocimientos

Leadership

Regulatory knowledge

Analytical thinking

Communication

Educación

B.S. in Engineering or Science

Descripción del empleo

Vantive seeks a Quality Management Representative (QMR) for its Twin Cities R&D multi-site campus. You will implement the Vantive Global Quality Management System and manage QMS documents for Quality, R&D, Regulatory, Facilities, across multiple sites.

You will lead PRRC, oversee VIP/MDDAP activities, train staff, manage NCR/CAPA and coordinate external inspections to ensure regulatory compliance and product quality.