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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 - Integrity, Accountability and Innovation, 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 Quality Operations, Engineering Manager is responsible for providing direction, leadership, training, mentoring, evaluation, and development to the Operations Quality Engineering and Technician staff. The Quality Operations Engineering Manager will provide resource allocation and technical support for calibration, maintenance, process validation, test method validation, equipment qualification, NCRs, CAPAs, complaint investigations, and change requests. The Quality Operations Engineering Manager provides resource allocation and technical support for continuous improvement of internal processes, supports quality issues impacting daily operations, leads or supports the execution of initiatives and projects to enhance quality systems, process and product performance, supports process validations, and analyzes data to present for monitoring and other optimization activities. The Quality Operations Engineering Manager will ensure compliance with regulations and standards and assist 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.
• Develop and maintain an effective workforce of quality engineers and technicians to facilitate accomplishment of quality goals and objectives.
• Evaluate and coordinate resource allocation for Quality Engineering activities. 
• Provide technical support and guidance for engineering change requests, calibration, process validation, test method validation, and equipment qualification. 
• Identify and remediate deficiencies in systems, product, process, and inspection.
• Collaborate with key stakeholders to develop and maintain effective systems, procedures, and forms.
• Supports NCRs, CAPAs, Asset Assessments, Audits, and Complaints related to materials and manufacturing issues.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Develop and maintain KPIs for monitoring process and product quality, perform analysis and interpret trends, and identify and activate appropriate actions as necessary.
• Undertake and complete assignments as designated by Management or by the department head.

Requirements

KNOWLEDGE, SKILLS AND ABILITIES:

• Excellent understanding of regulations applicable to Medical Devices (e.g., ISO 13485, QSR, etc.).
• Proven track record of leading quality engineering teams and driving process improvements.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Extensive experience in data analysis, statistical process control, process validation, and equipment qualification (IQ/OQ/PQ). 
• Technical knowledge of measuring equipment, equipment calibration, equipment maintenance, 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 organizing, planning, and prioritizing abilities.
• Solid problem analysis and decision-making ability and leadership skills.
• Must be able to adapt to change in the workplace and demonstrate flexibility with new ideas. 

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline; advanced degree preferred.
• 10+ years of experience in quality engineering or quality assurance in a medical device or regulated industry, with 3+ years of experience in a managerial role.
• Certification in quality management (e.g., CQE, CQM, SSBB) is a plus.

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.