Senior Quality Engineer, Medical Devices & CAPA

Katalyst CRO; Maple Grove (MN); Presencial; USD 90 000 - 120 000; Tempo integral

Resumo da oferta

Katalyst CRO in Maple Grove, MN, seeks a senior Quality Engineering leader to drive quality methodologies and CAPA programs across development, operations, and supplier networks. You will mentor teams, champion quality initiatives, and ensure compliance with regulatory and customer requirements for medical devices.

Responsibilities include leading cross-functional quality projects, implementing process controls, and advancing post-market surveillance activities while aligning with corporate

Qualificações

• 5+ years experience with BS; 3-4 years with MS.
• Medical device experience.
• CAPA ownership and post-market surveillance.
• Root cause analysis experience.
• Coordination with contract manufacturers and internal teams.
• Ability to work independently.
• Quality systems and CAPA processes.

Responsabilidades

• Leads quality engineering initiatives across departments and functions.
• Provides direction, coaching, and mentoring for engineering staff.
• Identifies and implements best-in-class Quality Engineering practices.
• Supports design changes activities and supplier corrective records.
• Authoring post market surveillance reports and periodic reviews.

Conhecimentos

CAPA ownership

Root cause analysis

Medical device experience

Coordination and communication with供应?

Formação académica

Bachelor's degree

Master's degree

Descrição da oferta de emprego

Katalyst CRO in Maple Grove, MN, seeks a senior Quality Engineering leader to drive quality methodologies and CAPA programs across development, operations, and supplier networks. You will mentor teams, champion quality initiatives, and ensure compliance with regulatory and customer requirements for medical devices.

Responsibilities include leading cross-functional quality projects, implementing process controls, and advancing post-market surveillance activities while aligning with corporate