Staff Quality Assurance Engineer – Medical Devices

Regulatory Jobs; Irvine (CA); Vor Ort; USD 103.000 - 171.000; Vollzeit

Zusammenfassung

Stryker is seeking a Staff Quality Engineer to join the Peripheral Vascular division in Irvine, CA. Onsite role supporting quality assurance, quality control, and continuous improvement across manufacturing operations, products, and processes.

Collaborate with cross‑functional teams and suppliers to resolve quality issues and drive CAPA, NCRs, and product disposition, ensuring compliance with regulatory requirements.

Qualifikationen

• Bachelor's degree in science, engineering, or related field.
• At least 4 years in quality engineering with CAPA, auditing, and statistics.
• Experience with risk assessments in regulated environments.
• Proficient in data analysis and reporting with MS Office.

Aufgaben

• Drive product and process quality performance with cross-functional teams.
• Own nonconformances, CAPAs, MRB, and product disposition.
• Collaborate with suppliers on supplier quality and PPAP.
• Monitor quality metrics and apply statistical methods.
• Support audits and regulatory compliance.
• Develop and maintain quality system documentation.
• Participate in internal and external audits.

Kenntnisse

Quality engineering

CAPA & audits

Risk management

Statistical analysis

Cross-functional collaboration

Ausbildung

Bachelor's degree in science/engineering

Tools

Microsoft Office

Quality management software

Jobbeschreibung

Stryker is seeking a Staff Quality Engineer to join the Peripheral Vascular division in Irvine, CA. Onsite role supporting quality assurance, quality control, and continuous improvement across manufacturing operations, products, and processes.

Collaborate with cross‑functional teams and suppliers to resolve quality issues and drive CAPA, NCRs, and product disposition, ensuring compliance with regulatory requirements.