QA Lead – Medical Devices (ISO 13485) Compliance | Hybrid

Halma plc; Malvern (Chester County); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Keeler, part of Halma, seeks a QA professional to lead quality assurance activities across US operations in Malvern, PA. The role focuses on ensuring compliant output, driving continuous improvement, and supporting ISO 13485 compliance and customer audits.

Responsibilities include CAPA management, change control, risk assessment, and monthly KPI reporting. A strong QA background in regulated manufacturing is required, with hybrid work and occasional travel.

Qualifications

• Experience and working knowledge of Quality Assurance in manufacturing/regulated environments.
• Proficient in CAPAs, change control and audit processes.
• Familiarity with ISO 13485:2016 and US medical device regulations.

Responsibilities

• Lead QA activities within Keeler USA operations to ensure compliant output.
• Drive QA projects and continuous improvement across processes.
• Prepare and deliver KPI reporting and risk assessments.
• Support QMS induction and training for new starters.

Skills

Quality Assurance

CAPAs

Audits

Root cause analysis (5 Whys, Fishbone)

Risk Management

Change control

ISO 13485 knowledge

QMS / eQMS

Tools

QMS software

FMEA

Job description

Keeler, part of Halma, seeks a QA professional to lead quality assurance activities across US operations in Malvern, PA. The role focuses on ensuring compliant output, driving continuous improvement, and supporting ISO 13485 compliance and customer audits.

Responsibilities include CAPA management, change control, risk assessment, and monthly KPI reporting. A strong QA background in regulated manufacturing is required, with hybrid work and occasional travel.