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
