Quality Engineer - Azer Scientific

MEA - MidAtlantic Employers’ Association; Morgantown (PA); On-site; USD 70,000 - 95,000; Full time

Job summary

Azer Scientific in Morgantown, PA is seeking a Quality Engineer to drive continuous quality improvements within our ISO 13485:2016 and 21 CFR 820 aligned QMS. You will ensure finished products and processes meet customer requirements and internal procedures.

This on-site role supports customer complaints, CAPA, deviation handling, and supplier quality efforts while coordinating training and documentation across the quality team. An engineering degree or equivalent experience is required.

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.
• Six Sigma certification 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 CAPAs.
• Lead actions to prevent nonconformities in product, process and QMS.
• Oversee process validation, tests, controls and documentation improvements.
• Manage calibration process of internal devices.
• Create, review and implement SOPs, work instructions and forms.
• Participate in new product design discussions and update product specs and materials.
• Support vendor qualification and perform vendor audits; prepare quality reports.
• Create nonconforming reports for vendor issues and request corrective actions.
• Follow and improve QMS procedures to ensure compliance of manufactured products.
• Coordinate employee training and maintain QMS records.
• Perform other duties as assigned.

Skills

Quality standards

Decision making

Leadership

Time management

Numerical skills

MS Office

Education

Bachelor's degree in Engineering

Certified Quality Auditor (CQA)

Six Sigma certification

ISO 14791:2019 risk assessment (preferred)

Tools

NetSuite

Microsoft ERP

Visio

Adobe Acrobat

Job description

(Full Time Opportunity)

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

Required Experience:

• 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

Keyword: Quality Engineer, Sr. Quality Engineer, Laboratory, QMS