Senior Quality Engineer - Medical Devices & Regulatory

Volpi Manufacturing Co. Inc.; City of Auburn (NY); Presencial; USD 65.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Salary range

401(k)

Health coverage

Dental & vision

Training & growth

Work culture

Descripción de la vacante

Volpi Group in Auburn, NY is seeking an experienced Senior Quality Engineer to join the Global Quality & Regulatory team. You will ensure product quality and regulatory compliance across development and manufacturing, collaborating with R&D, Manufacturing Engineering, suppliers, and customers.

The role requires 4+ years in a regulated environment, expertise in QMS and ISO 9001/13485, and occasional international travel (~10%).

Formación

• Bachelor degree in a Scientific, Technical, or Business discipline.
• 4+ years in a manufacturing facility.
• Experience in medical device or other highly regulated environments.
• Experience with QMS, validation and verification, and CAPA processes.
• Audit experience (internal, external, supplier, or customer).

Responsabilidades

• Provide quality engineering expertise to R&D and Manufacturing Engineering teams in compliance with ISO standards, FDA regulations, and internal policies.
• Support New Product Introduction (NPI), product transfers, and product lifecycle management.
• Manage non-conformances, CAPA, complaints, validations, change requests, and quality events.
• Contribute to regulatory strategies for development projects.
• Analyze quality data using statistical approaches and drive continuous improvement initiatives.
• Support audits (internal, external, supplier, and customer).
• Maintain and improve the Quality Management System (QMS) in alignment with global quality strategies.
• Lead or support risk management, safety, and surveillance activities.
• Collaborate with cross-functional teams to ensure compliance across the entire product lifecycle.
• Willingness to travel internationally (~10%).

Conocimientos

Quality engineering

ISO standards

Regulatory knowledge

CAPA

QMS

Audits

Data analysis

Cross-functional collaboration

Educación

Bachelor degree in Science/Engineering/Business

Herramientas

Microsoft Office

Descripción del empleo

Volpi Group in Auburn, NY is seeking an experienced Senior Quality Engineer to join the Global Quality & Regulatory team. You will ensure product quality and regulatory compliance across development and manufacturing, collaborating with R&D, Manufacturing Engineering, suppliers, and customers.

The role requires 4+ years in a regulated environment, expertise in QMS and ISO 9001/13485, and occasional international travel (~10%).