Senior Quality Systems Engineer – Medical Devices

Fisher Paykel Healthcare; San Diego (CA); Presencial; USD 67.000 - 101.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Employee share program

Profit share bonus

Life insurance

Health insurance discounts

Training programs

Career progression

Free parking

Descripción de la vacante

Fisher & Paykel Healthcare is seeking a Senior QSE to drive QMS improvements and act as a subject matter expert for Design Controls.

You will partner with product development, clinical, marketing and regulatory teams to ensure compliance with QMS and international regulations as products reach markets.

The role requires 5+ years in medical devices, a science/engineering degree, and strong risk management and CAPA leadership capabilities.

Formación

• Minimum 5+ years in medical device industry with Design Quality Engineering.
• Tertiary qualification in Science or Engineering.
• Understanding of 21 CFR 820 and ISO 13485.
• Experience with verification and validation activities.
• Knowledge of ISO 14971 Risk Management.
• Familiarity with FDA and EU regulations.
• Experience leading CAPAs.
• Experience with change control.
• Exposure to statistical analysis techniques.
• Usability engineering experience preferred.
• Holistic approach to product development.

Responsabilidades

• Lead QMS improvements and act as SME for Design Controls.
• Provide training and guidance to teams.
• Collaborate with product development, clinical, marketing and regulatory teams.
• Ensure compliance to QMS and regulatory requirements.

Conocimientos

Quality Engineering

CAPA leadership

Change control

QMS compliance

Regulatory knowledge

Risk management

Communication skills

Statistics awareness

Usability engineering

Product development

Educación

Bachelor's in Science or Engineering

Descripción del empleo

Fisher & Paykel Healthcare is seeking a Senior QSE to drive QMS improvements and act as a subject matter expert for Design Controls.

You will partner with product development, clinical, marketing and regulatory teams to ensure compliance with QMS and international regulations as products reach markets.

The role requires 5+ years in medical devices, a science/engineering degree, and strong risk management and CAPA leadership capabilities.