New World Medical · 7 hours ago
Senior Engineer, Quality - Operations
Rancho Cucamonga, CA
Full-time
Onsite
Senior Level
$98K/yr - $112K/yr
5+ years expNew World Medical is a mission-driven company focused on preserving and enhancing vision through innovative ophthalmic surgical devices. The Senior Engineer, Quality - Operations is responsible for investigating deviations and failures, ensuring compliance with regulations, and providing quality engineering support to improve internal processes.
EyewearHealth CareMedical Device
Responsibilities
Perform all work in compliance with New World Medical’s company policy and Quality System, as well as applicable regulations and standards
Supports quality issues impacting daily operations
Collaborates with Quality Assurance, Operations, and Engineering on product and process improvement as well as efficiency of inspection activities
Collaborate with key stakeholders to develop and maintain effective procedures, forms, and systems
Supports NCRs, CAPAs, SCARs, and Complaints related to materials and manufacturing issues
Maintain KPIs for monitoring of the process and/or product quality, perform analysis, and interpret trends, identifying and activating appropriate actions as necessary
Execute quality deliverables associated with internal engineering changes and internal validations for process and equipment
Supports internal and external audits by participating in preparation activities and addressing audit findings
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Reviews and approves Finished Goods Device History Record (DHRs) to release product to inventory
Undertake and complete assignments as designated by Quality Manager or by the department head
Qualification
Required
Excellent understanding of regulations applicable to Medical Devices (e.g., ISO 13485, QSR, etc.)
Equipment and process validation experience (IQ/OQ/PQ)
Technical knowledge of measuring equipment, equipment calibration, and measurement system analysis
Proficiency in Microsoft Office Applications (MS Word, MS Excel, MS PP, MS Outlook)
Ability to communicate in writing and orally with auditors, suppliers, supervisors, and co-workers
Demonstrate strong organization, planning, and prioritizing abilities
Must be able to adapt to change in the workplace and demonstrate flexibility with new ideas
Must be self-motivated and a good team player
5+ years of Quality Engineering experience preferrable in the Medical Device Industry
Bachelor's degree in engineering or equivalent science field, required
Preferred
Additional professional certifications, a plus (e.g., CQE, SSGB, etc.)
Benefits
Medical, Dental, and Vision Insurance
401(k) with Profit Share
Bonus Opportunities
Flexible Work Schedules
Free Onsite Daily Lunches to foster team connection
Career Development Program
Tuition Assistance (after 1 year of service)
Cell Phone & Home Office Stipends
Wellness & Employee Assistance Programs
Company Events & Recognition
And more!
Company
New World Medical
New World Medical is preserve and enhance vision by delivering innovations to Benefit Humanity and supporting medical cutting edge eye care.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Khalid Mansour
President & Chief Operating Officer
Keely Smith, CSC
Human Resources Business Partner
Recent News
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