Quality Engineer: QMS, CAPA & Compliance Lead

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

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.