Quality Engineer - Azer Scientific

MidAtlantic Employers' Association; Morgantown (PA); On-site; USD 85,000 - 110,000; Full time

Job summary

Azer Scientific in Morgantown, PA, is seeking a Quality Engineer to drive continual improvement of the Quality Management System and ensure compliance with ISO 13485:2016 and 21 CFR 820. This on-site role supports customer requirements, internal procedures, and product quality across all finished goods.

The ideal candidate has a Bachelor's in Engineering or 3–5 years of equivalent experience, plus knowledge of cGMP and CAPA processes.

Qualifications

• 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.

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 actions (CAPAs).
• Initiate and lead actions to prevent nonconformities relating to product, process, and QMS.
• Manage Process validation, tests, controls, documentation and improvements as needed.
• Manage calibration process of internal devices.
• Create, review, and implement processes, procedures and other documentation including SOPs, Work Instructions & forms.
• Participate in New product design process and discuss/update Product specifications and raw materials.
• Support on vendor qualification process, perform vendor audits, and prepare quality reports.
• Create Nonconforming reports for vendor issues and communicate with vendors to request corrective actions.
• Follow and improve QMS procedures to ensure manufactured products meet requirements.
• Coordinate employee training & maintain records related to the QMS.
• Perform other duties as assigned.

Skills

cGMP

FMEA

Decision making

Leadership

Time management

Organizational skills

Numerical skills

Education

Bachelor’s degree in Engineering

Certified Quality Auditor (CQA)

ISO 14791:2019 risk assessment (preferred)

Tools

NetSuite

Microsoft ERP

Job description

With over 30 years of laboratory expertise, our team atAzer Scientific is knowledgeable, motivated, andeager to assist you.

We are here to provide technical support and detailed productinformation to ensure our customers are getting the products to bestsuit their application.

We understand the crucial role that laboratory professionalsplay in the diagnosis, treatment, and research of diseases, and wewant to ensure that they have the best products available to them asthey continue to make a difference in the lives of patients everywhere.

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

Position Summary

Under the supervision of the Quality Director, theQuality Engineer is responsible for the continualimprovement of Quality Management Systems (QMS), ensure compliancewith ISO 13485:2016 and 21 CFR 820, to secure all finished productsand Azer Scientific processes are managed according to Customerrequirements, Internal Procedures and regulations. (Customercomplaint management, Problem solving, CAPA, 8D, communication,cGMP, QMS, Process Validation)

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

Duties Responsibilities:

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

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

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

Manage Process validation, tests, controls, document and performimprovements, as needed.

Manage calibration process of internal devices

Create, review, and implement processes, procedures and otherdocumentation 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 performvendor audits, and prepare quality reports.

Create Nonconforming reports for vendor issues and communicatewith vendors to request corrective actions.

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

Coordinate employee training & maintain records related tothe QMS

Perform other duties as assigned.

Skills:

Strong knowledge of quality standards [cGMP, FMEA and respectivecontrols 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

Experience and Skills:

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

Requirements:

Driver license and ability to move from one site to another

3+ years of Quality Management System experience, cGMP, Regulatoryrequirements 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, eyesafety glasses, lab coat, hearing protectors, work boots