Senior Quality Systems Engineer – Medical Devices (Relocation)

Fisher & Paykel Healthcare; Tijuana; Presencial; MXN 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Employee share purchase scheme

Profit sharing

Training programs

Career progression

Free Parking

Campus facilities

Descripción de la vacante

Fisher & Paykel Healthcare is seeking a Senior Quality & Design Engineer to lead QMS improvements and act as the Design Controls SME, with 5+ years in medical devices. Ability to navigate regulatory requirements and drive CAPAs is essential.

The role will partner with product development, clinical, marketing and regulatory teams to ensure compliant product design and successful market entry, including training and cross-functional collaboration.

Formación

• A minimum 5+ years related experience in the medical device industry or similar regulated field.
• Tertiary qualification in Science or Engineering.
• Knowledge of 21CFR820 and ISO 13485 quality management systems.
• Experience with product verification and validation activities.
• Strong risk management knowledge (ISO 14971).
• Familiarity with FDA and international regulations including the EU.
• Experience leading effective CAPAs.
• Experience with change control processes.
• Exposure to statistical analysis techniques.
• Exposure to usability engineering is a plus.
• Holistic approach to product development.

Responsabilidades

• Identify and implement QMS improvements as Senior QSE.
• Be a subject matter expert for Design Controls.
• Provide training and guidance to support business plans and regulatory compliance.
• Partner with product development, clinical, marketing and regulatory teams.

Conocimientos

Quality engineering

Regulatory knowledge

Risk management

CAPA handling

Change control

Statistical analysis

Verification & validation

Usability engineering

Product development

Communication skills

Educación

Science or Engineering degree

Descripción del empleo

Fisher & Paykel Healthcare is seeking a Senior Quality & Design Engineer to lead QMS improvements and act as the Design Controls SME, with 5+ years in medical devices. Ability to navigate regulatory requirements and drive CAPAs is essential.

The role will partner with product development, clinical, marketing and regulatory teams to ensure compliant product design and successful market entry, including training and cross-functional collaboration.