Senior Quality Engineer, Medical Devices - Operations

New World Medical; Rancho Cucamonga (CA); On-site; USD 100,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

401(k) with Profit Share

Bonus Opportunities

Career Development Program

Tuition Assistance

Cell Phone Stipends

Wellness & Employee Assistance Program

Company Events & Recognition

And more!

Job summary

New World Medical in Rancho Cucamonga, CA, seeks an experienced Senior Engineer, Quality - Operations to lead investigations on NCRs, CAPAs and complaints, analyze data, and ensure regulatory compliance. This role focuses on continuous improvement of internal processes and quality performance within the operations team.

You will support internal validations, audits, and engineering changes, collaborate with QA, Operations, and Engineering, and drive corrective actions.

Qualifications

• Regulatory knowledge for Medical Devices (ISO 13485, QSR)
• IQ/OQ/PQ validation experience
• Measuring equipment calibration and Measurement System Analysis
• Proficiency with MS Office applications
• Strong written and verbal communication with auditors and teams
• Excellent organization and prioritization abilities
• Ability to adapt to change and work well in a team

Responsibilities

• Investigate NCRs, CAPAs, and Complaints and document findings
• Analyze data for monitoring and process optimization
• Ensure compliance with regulations and standards in QA and operations
• Lead or support initiatives to improve quality performance
• Support internal validations and audits; assist with audit findings
• Collaborate with QA, Operations, and Engineering on product/process improvements
• Review and approve documentation related to finished goods and changes

Skills

Regulatory knowledge

Calibration experience

Measurement systems analysis

MS Office proficiency

Written and verbal communication

Organization & prioritization

Adaptability

Team player

Education

Bachelor's degree in Engineering or related Science

CQE or similar certifications (plus)

Tools

MS Office (Word, Excel, PowerPoint, Outlook)

Job description

New World Medical in Rancho Cucamonga, CA, seeks an experienced Senior Engineer, Quality - Operations to lead investigations on NCRs, CAPAs and complaints, analyze data, and ensure regulatory compliance. This role focuses on continuous improvement of internal processes and quality performance within the operations team.

You will support internal validations, audits, and engineering changes, collaborate with QA, Operations, and Engineering, and drive corrective actions.