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.