Senior Design Quality Engineer - Medical Devices Risk Lead

Regulatory Jobs; Mansfield (MA); Híbrido; USD 97.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401k Matching

Tuition Reimbursement

Paid Holidays

Flexible Vacation Time

Descripción de la vacante

Smith+Nephew is seeking a Senior Design Quality Engineer in Mansfield, MA. You will support the sustaining and lifecycle management of Sports Medicine Joint Repair products, ensuring safety, efficacy, and regulatory compliance.

Responsibilities include leading risk management, design quality oversight for verification and validation, investigations of complaints and CAPAs, and collaboration with cross-functional teams to meet quality and business goals.

Formación

• BS in Engineering or related field required.
• 5+ years in medical device or regulated environment.
• Knowledge of FDA QSR, ISO 13485 and ISO 14971.

Responsabilidades

• Serve as Design Quality representative for product support and lifecycle management.
• Lead risk management, including FMEA and risk controls.
• Provide design quality oversight for design verification/validation and validation activities.
• Investigate complaints, nonconformances, CAPAs and post-market surveillance.
• Review and approve quality/engineering documentation for compliance.
• Collaborate with Regulatory Affairs, Operations, R&D, Manufacturing, Marketing, Clinical and Supplier Quality.

Conocimientos

5+ years medical device quality

Cross-functional collaboration

Strong communication

Quality systems knowledge

Educación

Bachelor of Science in Engineering or related field

Descripción del empleo

Smith+Nephew is seeking a Senior Design Quality Engineer in Mansfield, MA. You will support the sustaining and lifecycle management of Sports Medicine Joint Repair products, ensuring safety, efficacy, and regulatory compliance.

Responsibilities include leading risk management, design quality oversight for verification and validation, investigations of complaints and CAPAs, and collaboration with cross-functional teams to meet quality and business goals.