Senior Quality Engineer - Medical Device Innovation

Regulatory Jobs; Rancho Cucamonga (CA); Vor Ort; USD 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, and Vision Insurance

401(k) with Profit Share

Bonus Opportunities

Career Development Program

Tuition Assistance (after 1 year of服务)

Cell Phone Stipends

Wellness & Employee Assistance Program

Company Events & Recognition

Zusammenfassung

New World Medical is seeking a Senior Engineer, Quality - Operations to investigate deviations and failures, analyze data for monitoring and optimization, and ensure compliance with medical device regulations. The role supports QA and Operations, drives continuous improvement, validates processes and equipment, and assists audits.

Ideal candidates have >5 years in quality engineering for medical devices, a bachelor’s degree in engineering, and certifications like CQE/SSGB are a plus.

Qualifikationen

• Bachelor’s degree in engineering or equivalent science field required.
• 5+ years of Quality Engineering experience in Medical Devices.
• CQE or SSGB certifications are a plus.

Aufgaben

• Ensure compliance with company policy and Quality System and regulations.
• Collaborate with QA, Operations, and Engineering on product/process improvements.
• Maintain KPIs for process and product quality and analyze trends.
• Support NCRs, CAPAs, SCARs, and related complaints.
• Assist with internal and external audits and validations.

Kenntnisse

Regulatory knowledge

Validation experience

Measurement equipment knowledge

MS Office proficiency

Written and verbal communication

Organization and prioritization

Adaptability

Team player

Ausbildung

Bachelor’s degree in engineering or equivalent

CQE

SSGB

Tools

Calibration equipment

Measurement system analysis

Jobbeschreibung

New World Medical is seeking a Senior Engineer, Quality - Operations to investigate deviations and failures, analyze data for monitoring and optimization, and ensure compliance with medical device regulations. The role supports QA and Operations, drives continuous improvement, validates processes and equipment, and assists audits.

Ideal candidates have >5 years in quality engineering for medical devices, a bachelor’s degree in engineering, and certifications like CQE/SSGB are a plus.