Quality Engineer - Azer Scientific

Job Description

Job Description

Quality Engineer

Azer Scientific

Morgantown, PA

(Full Time Opportunity)

With over 30 years of laboratory expertise, our team at Azer Scientific is knowledgeable, motivated, and eager to assist you.

We are here to provide technical support and detailed product information to ensure our customers are getting the products to best suit their application.

We understand the crucial role that laboratory professionals play in the diagnosis, treatment, and research of diseases, and we want to ensure that they have the best products available to them as they continue to make a difference in the lives of patients everywhere.

Our professional staff is available to make your Azer buying experience convenient, efficient, and enjoyable.

Position Summary

Under the supervision of the Quality Director, the Quality Engineer is responsible for the continual improvement of Quality Management Systems (QMS), ensure compliance with ISO 13485:2016 and 21 CFR 820, to secure all finished products and Azer Scientific processes are managed according to Customer requirements, Internal Procedures and regulations. (Customer complaint management, Problem solving, CAPA, 8D, communication, cGMP, QMS, Process Validation)

This is an on-site role working five (5) days per week.

Duties Responsibilities:

Manage customer complaints, create cases/tickets and communicate with customers to provide post-delivery support.

Provide support for deviation, investigations, including root cause analysis, and corrective & preventive action (CAPAs)

Initiate and lead actions to prevent the occurrence of nonconformities relating to product, process, and QMS.

Manage Process validation, tests, controls, 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 & forms.

Participate on 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.

Follow and improve relevant Quality Management System procedures to ensure manufactured products meet requirements.

Coordinate employee training & maintain records related to the QMS

Perform other duties as assigned.

Skills:

Strong knowledge of quality standards [cGMP, FMEA and respective controls 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:

Bachelor’s degree in Engineering, or 3-5 years of equivalent experience

Certified Quality Auditor (CQA), recommended

Risk assessment management based on ISO 14791:2019, preferred

Six Sigma certification, preferred

Requirements:

Drive license and ability to move from one site to another

3+ years of Quality Management System experience, cGMP, Regulatory requirements related to CRF 21 Part 820 & Parts 210/211

Proficient in ERP system [NetSuite or Microsoft preferred]

Ability to lift materials and products up to 50 pounds

May require the use of PPE include but not limited to: mask, eye safety glasses, lab coat, hearing protectors, work boots