Quality Engineer - Azer Scientific

MidAtlantic Employers' Association•Morgantown, PA

8d•Onsite

About The Position

Azer Scientific is seeking a Quality Engineer to continually improve its Quality Management Systems (QMS) and ensure compliance with ISO 13485:2016 and 21 CFR 820. Under the supervision of the Quality Director, this role helps ensure that finished products and company processes meet customer requirements, internal procedures, and regulatory requirements. Areas of focus include customer complaint management, problem solving, CAPA, 8D, communication, cGMP, QMS, and process validation. This is a full-time, on-site role in Morgantown, Pennsylvania, working five days per week. The Quality Engineer manages customer complaints and investigations, process validation, calibration, QMS documentation and training, vendor quality activities, and support for new product design. The role may require travel between sites and handling materials and products weighing up to 50 pounds.

Requirements

Bachelor’s degree in Engineering or 3–5 years of equivalent experience.
At least 3 years of Quality Management System experience.
Experience with cGMP and regulatory requirements related to 21 CFR Part 820 and Parts 210/211.
Proficiency in an ERP system; NetSuite or Microsoft is preferred.
Valid driver’s license and ability to travel between sites.
Ability to lift materials and products weighing up to 50 pounds.
Strong knowledge of quality standards.
Ability to make considered decisions and communicate them effectively.
Strong leadership, time-management, and organizational skills.
Good numerical skills and an understanding of statistics.
Proficiency with MS Office, including Excel, Word, and Visio, and Adobe Acrobat.

Nice To Haves

Knowledge of FMEA and related controls.
Certified Quality Auditor (CQA) certification is recommended.
Risk assessment management based on ISO 14791:2019 is preferred.
Six Sigma certification is preferred.

Responsibilities

Manage customer complaints, create cases or tickets, and communicate with customers to provide post-delivery support.
Support deviation investigations, including root cause analysis and corrective and preventive actions (CAPAs).
Initiate and lead actions to prevent nonconformities relating to products, processes, and the QMS.
Manage process validation, tests, and controls; document and perform improvements as needed.
Manage the calibration process for internal devices.
Create, review, and implement processes, procedures, and other documentation, including SOPs, work instructions, and forms.
Participate in the new product design process and discuss or update product specifications and raw materials.
Support vendor qualification, potentially perform vendor audits, and prepare quality reports.
Create nonconformance reports for vendor issues and communicate with vendors to request corrective actions.
Follow and improve relevant QMS procedures to ensure manufactured products meet requirements.
Coordinate employee training and maintain records related to the QMS.
Perform other duties as assigned.