Senior Supplier Quality Engineer – Life Sciences

Regulatory Jobs; Chaska (MN); Presencial; USD 100.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Paid time off

Medical/dental/vision insurance

401(k)

Descripción de la vacante

Beckman Coulter Diagnostics, part of Danaher, seeks a Senior Supplier Quality Engineer in the Instrument Quality group in Chaska, MN, on-site. The role ensures compliance with the Quality Management System and relevant regulations, partnering with North America supplier quality.

You will lead supplier qualification, corrective actions, audits, and continuous improvement initiatives to deliver world-class medical devices.

Formación

• Scientific degree in a relevant field (Mechanical, Electrical, Chemical, etc.)
• 5+ years quality experience with a bachelor's degree, 3+ years with a master's degree
• Certified Quality Engineering certification preferred.
• Experience with 21CFR820 and ISO14971

Responsabilidades

• Plan supplier selections and qualifications, change notifications, audits and supplier scorecards.
• Develop supplier material control plans as part of product qualification.
• Lead root cause and corrective action analysis for supplier-related issues.
• Visit suppliers to resolve product performance concerns.
• Recommend field actions to product regulatory committee.
• Lead Kaizen events to improve processes and reduce waste.

Conocimientos

Quality systems

Supplier quality

Root cause analysis

Audits

Lean / Kaizen

Educación

Bachelor's degree in a relevant field

Master's degree in a related field

Herramientas

FDA 21 CFR 820

ISO 14971

Descripción del empleo

Beckman Coulter Diagnostics, part of Danaher, seeks a Senior Supplier Quality Engineer in the Instrument Quality group in Chaska, MN, on-site. The role ensures compliance with the Quality Management System and relevant regulations, partnering with North America supplier quality.

You will lead supplier qualification, corrective actions, audits, and continuous improvement initiatives to deliver world-class medical devices.