Quality Engineer - Medical Devices QMS Lead (Hybrid PA)

Halma plc; Pennsylvania; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Keeler USA, a part of Halma, is seeking an experienced Quality Assurance professional to lead QA activities in its Malvern, PA operations. The role focuses on maintaining ISO 13485:2016 compliance, managing CAPAs, and driving continuous improvement across manufacturing processes.

You will collaborate with Global QA to ensure robust QMS implementation and support audits of internal and supplier processes while guiding incident and complaint investigations and continual quality enhancements.

Qualifications

• Experience in Quality Assurance within a manufacturing environment.
• Minimum 3 years of relevant experience in medical devices, pharmaceuticals, or another highly regulated industry.
• Lead Auditor training and certification.
• Solid knowledge of ISO 13485:2016 and USA regulations.
• Experience with CAPAs (Corrective and Preventive Actions).
• Risk Management to ISO 14971.

Responsibilities

• Oversee the QA system within Keeler USA Operations, ensuring compliant output across processes.
• Develop and drive quality/operations improvement projects.
• Support pharmaceutical compliance and continuous improvement initiatives.
• Conduct gap analyses and ensure readiness for regulatory audits.

Skills

Quality Assurance

Regulatory knowledge

Auditing

CAPA management

Risk management

Education

Bachelor's degree in a relevant field

Tools

QMS software

eQMS

Job description

Keeler USA, a part of Halma, is seeking an experienced Quality Assurance professional to lead QA activities in its Malvern, PA operations. The role focuses on maintaining ISO 13485:2016 compliance, managing CAPAs, and driving continuous improvement across manufacturing processes.

You will collaborate with Global QA to ensure robust QMS implementation and support audits of internal and supplier processes while guiding incident and complaint investigations and continual quality enhancements.