Quality Systems Leader - Medical Devices & AI Innovation

ENNOVI; Attleboro (MA); Presencial; USD 90 000 - 120 000; Tempo integral

Resumo da oferta

Ennovi Medical seeks a Quality Manager to own the development and implementation of the quality system across ISO9001, IATF16949, and ISO13485. You will be the Management Representative and lead validation efforts, audits, and continuous improvement initiatives.

You will manage a quality team, drive internal and supplier audits, and collaborate with customers to ensure compliance and product quality. Join Ennovi’s mission to deliver safer, smarter medical solutions.

Qualificações

• Bachelor of Arts or Science Degree or Higher.
• Automotive manufacturing experience including AIAG core tools, LPA’s and RFMEA’s.
• Six sigma black belt and lean experience / certification preferred.

Responsabilidades

• Develop, document, implement and register Quality Systems for ISO9001, IATF16949 and ISO13485.
• Lead medical validation activities (IQ, OQ and PQ) per ISO 13485.
• Provide procedural and policy guidance related to quality systems and initiatives.
• Conduct training and monitoring to ensure adherence to quality standards and procedures.
• Manage and supervise the Quality staff in daily responsibilities.
• Champion the internal audit system and customer audits (e.g., VDA6.3).
• Develop metrics tracking and reporting for manufacturing and process quality.
• Lead MRB committee to disposition non-conformances and initiate corrective actions.
• Coordinate document control activities as required by standards.
• Monitor monthly and annual quality improvement goals for Ennovi corporate.

Conhecimentos

Quality systems

Leadership

Training

Formação académica

Bachelor's degree or higher

Ferramentas

AIAG core tools

LPA’s

RFMEA’s

Descrição da oferta de emprego

Ennovi Medical seeks a Quality Manager to own the development and implementation of the quality system across ISO9001, IATF16949, and ISO13485. You will be the Management Representative and lead validation efforts, audits, and continuous improvement initiatives.

You will manage a quality team, drive internal and supplier audits, and collaborate with customers to ensure compliance and product quality. Join Ennovi’s mission to deliver safer, smarter medical solutions.