Staff Quality Process Engineer - Onsite Leader (Chandler)

Hardware FYI; Chandler (AZ); Hybride; USD 89 000 - 149 000; Plein temps

Résumé du poste

Stryker Corporation is seeking a Staff Quality Process Engineer for onsite leadership in quality assurance, control, and preventive activities in Chandler, Arizona. The role emphasizes continuous improvement of products and processes and requires mentoring across multiple domains.

You will work with operations and cross-functional teams to address top quality issues, lead NC/CAPA, and drive risk-based decisions.

Qualifications

• Bachelor's degree in engineering or related field.
• 5+ years of experience in medical device quality.
• Experience with US and international medical device regulations.
• Product transfer experience.
• Knowledge of ISO 13485, GDP, GMP.
• Strong communication and project management skills.

Responsabilités

• Collaborate with operations to ensure quality performance of products and processes.
• Lead investigations and CAPA activities, and drive corrective actions.
• Mentor and provide technical direction in quality topics and problem-solving.
• Oversee change management and validation activities for products and processes.
• Support manufacturing transfers and risk management practices.

Connaissances

CAPA

Audits

Statistics

Risk management

Quality leadership

Project management

Cross-functional

Formation

BSc Engineering

CQE

CRE

Description du poste

Stryker Corporation is seeking a Staff Quality Process Engineer for onsite leadership in quality assurance, control, and preventive activities in Chandler, Arizona. The role emphasizes continuous improvement of products and processes and requires mentoring across multiple domains.

You will work with operations and cross-functional teams to address top quality issues, lead NC/CAPA, and drive risk-based decisions.