Senior Engineer Quality - Operations

New World Medical, Inc.•Rancho Cucamonga, CA

3h•$100,000 - $110,000•Onsite

About The Position

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.

Requirements

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.
5+ years of Quality Engineering experience preferrable in the Medical Device Industry.
Bachelor’s degree in engineering or equivalent science field, required.

Nice To Haves

Additional professional certifications, a plus (e.g., CQE, SSGB, etc.)

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.