Staff Quality Engineer - Medical Devices & NPI Lead

Stryker Corporation; Irvine (CA); Sur place; USD 103 000 - 171 000; Plein temps

Résumé du poste

Stryker Corporation in Irvine, CA is seeking a Staff Quality Engineer to lead quality activities for new product introductions, design transfer, and regulatory compliance in a fast-paced, regulated environment.

You will drive PFMEA, validation strategies, inspection planning, and supplier qualification while ensuring right-first-time manufacturing and continuous improvement. 20% travel required.

Qualifications

• Bachelor degree in Engineering or related technical field.
• Minimum 4 years in quality, engineering or technical discipline.
• Experience in a regulated manufacturing environment.
• Knowledge of ISO 13485, GMP and GDP quality requirements.
• Lean Six Sigma training or DMAIC experience.

Responsabilités

• Lead quality activities for new product and process introductions.
• Develop PFMEA, risk mitigation and control strategies.
• Create inspection strategies, sampling plans and MSA approaches.
• Define and approve process validation strategies and reports.
• Apply statistical methods to CAPA, root-cause, and process improvements.
• Support design for manufacturing and supplier qualification activities.
• Represent Quality in design reviews and launch metrics.

Connaissances

Quality engineering

Risk management

FMEA

Statistical methods

Process validation

Formation

Bachelor of Science in Engineering

Outils

CQE (Certified Quality Engineer)

Description du poste

Stryker Corporation in Irvine, CA is seeking a Staff Quality Engineer to lead quality activities for new product introductions, design transfer, and regulatory compliance in a fast-paced, regulated environment.

You will drive PFMEA, validation strategies, inspection planning, and supplier qualification while ensuring right-first-time manufacturing and continuous improvement. 20% travel required.