Senior Engineer Quality - Operations

New World Medical Inc; Rancho Cucamonga (CA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) profit sharing

Bonus opportunities

Career development program

Tuition assistance

Cell phone stipend

Wellness & Employee Assistance

Company events

Job summary

New World Medical Inc. is seeking a Senior Engineer, Quality - Operations in California to lead investigations on deviations and failures, analyze data for monitoring, and ensure regulatory compliance. The role focuses on continuous process improvements and supporting internal validations and audits.

The candidate will collaborate with QA, operations, and engineering to optimize inspection activities and maintain KPI-driven quality performance across daily operations.

Qualifications

• Excellent understanding of regulations applicable to Medical Devices (ISO 13485, QSR, etc.).
• Equipment and process validation experience (IQ/OQ/PQ).
• Technical knowledge of measuring equipment, calibration, and measurement system analysis.

Responsibilities

• Perform all work in compliance with the company Quality System and applicable regulations.
• Support quality issues impacting daily operations and assist with audits.
• Collaborate with QA, Operations, and Engineering on product/process improvements.
• Develop and maintain procedures, forms, and systems with stakeholders.
• Support NCRs, CAPAs, SCARs, and complaints related to materials/manufacturing.

Skills

Regulatory knowledge

Validation (IQ/OQ/PQ)

Measuring equipment

MS Office

Communication

Organization

Adaptability

Team player

Education

Bachelor's degree in engineering or equivalent science field

Job description

About New World Medical

Founded in 1990, New World Medical is a mission-driven company focused on preserving and enhancing vision through innovative ophthalmic surgical devices, including the Ahmed Glaucoma Valve and Kahook Dual Blade. We partner closely with eye care professionals to deliver tools that improve clinical outcomes and patient care. Guided by our core values - Gratitude, Collaboration, and Impact, we strive to make a meaningful impact in eye health worldwide. In support of our global mission, we proudly donate surgical equipment to charitable organizations to expand access to quality eye care.

Benefits starting Day One:

• Medical, Dental, and Vision Insurance
• 401(k) with Profit Share
• Bonus Opportunities
• Career Development Program
• Tuition Assistance (after 1 year of service)
• Cell Phone Stipends
• Wellness & Employee Assistance Programs
• Company Events & Recognition
• And more!

Be part of something meaningful—join the team at New World Medical.

Job Summary:

The Senior Engineer, Quality - Operations is responsible for performing investigations on deviations and failures for NCRs, CAPAs, and complaints, analyzing data to present for monitoring and other optimization activities, and ensuring compliance with regulations and standards. The Senior Engineer, Quality - Operations provides quality engineering support in quality assurance and other functions within operations with a focus on continuous improvement of internal processes, supports quality issues impacting daily operations, lead or support the execution of initiatives and projects to enhance quality performance, supports internal validations, and assists with internal and external audits.

ESSENTIAL JOB DUTIES AND 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.

Requirements

KNOWLEDGE, SKILLS AND ABILITIES:

• 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.

EDUCATION AND EXPERIENCE:

• 5+ years of Quality Engineering experience preferrable in the Medical Device Industry.
• Bachelor’s degree in engineering or equivalent science field, required.
• Additional professional certifications, a plus (e.g., CQE, SSGB, etc.)

PHYSICAL REQUIREMENTS:

• Must be able to remain in a stationary position at least 50% of the time.
• Occasionally move about inside the office and travel between office buildings to access and retrieve equipment, file cabinets, employee offices, office machinery, etc. This may include, but is not limited to, bending and walking.
• Must be able to safely slide, lift, carry, and/or handle items weighing up to 25 pounds on occasion. This may be performed with reasonable accommodation.
• Must be able to operate a computer and other office productivity devices, such as a computer printer, computer keyboard, calculator, etc.
• Must have the ability to sit, listen, speak, type, and move throughout the facility.
• Must be able to view computer screens and type for long periods of time.

This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.