Senior Quality Engineer, Medical Devices - Operations

Regulatory Jobs; Rancho Cucamonga (CA); Sur place; USD 110 000 - 150 000; Plein temps

Avantages offerts par ce poste

Medical, Dental, and Vision Insurance

401(k) with Profit Share

Bonus Opportunities

Career Development Program

Tuition Assistance (after 1 year of服務)

Cell Phone Stipends

Wellness & Employee Assistance

Résumé du poste

New World Medical, a mission-driven ophthalmic device company, is seeking a Senior Engineer, Quality - Operations to lead investigations of NCRs, CAPAs, and complaints, and to drive data-driven improvements in manufacturing quality.

The role focuses on compliance with ISO 13485 and QSR, supporting internal audits, validations, and quality deliverables while collaborating with QA, Operations, and Engineering to optimize processes and product quality.

Qualifications

• 5+ years Quality Engineering experience in Medical Devices.
• Bachelor's degree in engineering or equivalent science field required.
• Certifications such as CQE or SSGB are a plus.

Responsabilités

• Perform investigations on NCRs, CAPAs, and complaints.
• Analyze data and maintain KPIs for quality monitoring.
• Support audits, validations, and internal quality improvements.
• Collaborate with QA, Operations and Engineering on process improvements.
• Review and approve documentation and records for release.

Connaissances

Regulatory understanding

Quality systems

Measurement & calibration

MS Office proficiency

Written & verbal communication

Organization & planning

Adaptability

Team collaboration

Formation

Bachelor's degree in engineering or science

CQE, SSGB certifications (plus)

Outils

MS Office

Description du poste

New World Medical, a mission-driven ophthalmic device company, is seeking a Senior Engineer, Quality - Operations to lead investigations of NCRs, CAPAs, and complaints, and to drive data-driven improvements in manufacturing quality.

The role focuses on compliance with ISO 13485 and QSR, supporting internal audits, validations, and quality deliverables while collaborating with QA, Operations, and Engineering to optimize processes and product quality.