Senior Engineer, Quality

Regulatory Toolkit; Rancho Cucamonga (CA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

401(k) with Profit Share

Bonus Opportunities

Career Development Program

Tuition Assistance (after 1 year of服務)

Cell Phone Stipends

Wellness & Employee Assistance

Job summary

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.

Responsibilities

• 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.

Skills

Regulatory understanding

Quality systems

Measurement & calibration

MS Office proficiency

Written & verbal communication

Organization & planning

Adaptability

Team collaboration

Education

Bachelor's degree in engineering or science

CQE, SSGB certifications (plus)

Tools

MS Office

Job description

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.

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.