Senior Engineer, Quality - Operations

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
• 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!

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 c