Quality Engineer - Morgantown, United States - Electron Microscopy Sciences

Description

Quality Engineer

Morgantown, PA

Position supports two sites and candidates must be able to travel to our sites as needed

COMPANY SUMMARY

Inverness Graham, a Philadelphia based buyout firm that acquires innovative companies where technology is transforming traditional industry, has created a new Life Sciences and Diagnostics platform with the acquisitions of Electron Microscopy Sciences (EMS) and Azer Scientific. Founded in 1969, EMS is the most comprehensive source for all microscopy and general laboratory research fields. Azer Scientific was founded in 2003 and has grown into a leading healthcare supplier serving histology laboratories. The two brands share a common mission to partner with customers to drive service innovation within the life sciences and diagnostic industries and, today, serve customers across 100 countries.

POSITION SUMMARY

Under the supervision of the Quality Director, the Quality Engineer is responsible for keeping continual improvement of Quality Management Systems (QMS), ensure compliance with ISO 13485:2016, to secure all finished products and Azer Scientific processes are managed according to customer requirements, internal procedures, and regulations.

ESSENTIAL JOB FUNCTIONS

• Manage customer complaints, creating cases/tickets and communicate with customers to provide post-delivery support.
• Provide support for deviation, investigations, including root cause analysis, and corrective and preventive action (CAPAs).
• Initiate and lead actions to prevent the occurrence of nonconformities relating to product, process, and QMS.
• Manage process validation, tests, controls, and document and perform improvements as needed.
• Manage calibration process of internal devices.
• Create, review, and implement processes, procedures, and other documentation including SOPs, work instructions and forms.
• Participate in new product design process and be able to discuss/update product specifications and raw materials.
• Support on vendor qualification process, eventually perform vendor audits, and prepare quality reports.
• Create nonconforming reports for vendor issues and communicate with vendors to request corrective actions.
• Coordinate employee training and maintain records related to the QMS.
• Perform other responsibilities as assigned.

SKILLS AND ABILITIES

• Strong knowledge of quality standards (GMP, FMEA, CP preferred).
• Ability to make considered decisions and communicate them effectively.
• Strong leadership, time-management, and organizational skills.
• Good numerical skills and an understanding of statistics.
• MS Office: Excel, Word, Visio, Adobe Acrobat.

EDUCATION

• Bachelors degree in engineering or 3-5 years of equivalent experience.
• Certified Quality Auditor (CQA) is recommended.
• Six Sigma certification is preferred.
• Risk assessment management based on ISO 14791:2019 is preferred.

MINIMUM REQUIREMENTS

• 3+ years of Quality Management System experience, GMP, CFR /211.
• Proficient in ERP system (NetSuite or SAP preferred).
• Ability to lift materials and product up to 50 pounds.
• May require the use of safety equipment to include but not limited to: eye safety glasses, lab coat, hearing protectors, work boots, and hardhats.
• Drivers License and ability to move from one site to another.

Electron Microscopy Sciences/Azer Scientific provides equal employment opportunities to all persons and prohibits employment decisions based on race, religion, color, creed, national origin, sex, age, disability, political affiliation, protected veteran status, or sexual orientation.