Senior Quality Engineer, Endoscopy — Hybrid Role

Regulatory Jobs; San Jose (CA); Hybrid; USD 133.000 - 222.000; Vollzeit

Zusammenfassung

Stryker is hiring a Senior Staff Quality Engineer in the Endoscopy division, based in San Jose, CA. You will provide quality engineering leadership across QA, QC and preventive activities, driving continuous improvement of products and processes to meet regulatory requirements.

You will mentor teams, lead NC/CAPA activities, manage audits, and ensure compliance with ISO 13485, GMP and post-market requirements while partnering with customers and cross-functional teams to resolve top quality

Qualifikationen

• Bachelor’s degree in science, engineering or related discipline.
• Minimum 6 years of experience in Quality and/or R&D within the medical device industry.
• Strong knowledge of ISO 13485, GDP, GMP and U.S./international medical device regulations.
• Experience leading root cause investigations, CAPA, complaint investigations and post-market quality initiatives.

Aufgaben

• Lead quality initiatives and projects across the organization.
• Mentor teams and provide technical direction on NC/CAPA, investigations and risk management.
• Engage in internal and external audits with regulatory representatives and manage audit logistics.

Kenntnisse

Quality assurance

Medical device

Root cause investigations

CAPA

Regulatory compliance

Ausbildung

Bachelor’s degree in science/engineering

Master’s degree (preferred)

Jobbeschreibung

Stryker is hiring a Senior Staff Quality Engineer in the Endoscopy division, based in San Jose, CA. You will provide quality engineering leadership across QA, QC and preventive activities, driving continuous improvement of products and processes to meet regulatory requirements.

You will mentor teams, lead NC/CAPA activities, manage audits, and ensure compliance with ISO 13485, GMP and post-market requirements while partnering with customers and cross-functional teams to resolve top quality