Quality Engineer — Medical Devices, CAPA & Process Leader

NML Medical; Limerick (Montgomery County); On-site; USD 90,000 - 125,000; Full time

Job summary

Globus Medical is seeking a Quality Engineer to support musculoskeletal devices and instruments manufacturing. The role drives quality systems improvement, CAPA, and supplier quality in a regulated medical device environment.

You will work with cross-functional teams to resolve quality issues, validate processes, and ensure compliance with GMP, ISO 13485, and FDA QMSR. Collaboration across sites and leadership communication are essential.

Qualifications

• Bachelor’s degree in engineering, science, or related technical discipline.

Responsibilities

• Investigate product, process, and system quality issues (NCs or deviations).
• Analyze manufacturing data to improve process performance and quality.
• Own supplier quality: SCARs, supplier qualifications, and supplier audits.
• Evaluate changes to supplier processes and assess QMS impact.
• Lead CAPA activities, root cause analysis, and effectiveness verification.
• Participate in risk management activities (PFMEAs) and control plan maintenance.
• Support internal and external audits and prepare responses to findings.

Skills

Statistical methods

Minitab

Lean Manufacturing

Six Sigma

ASQ certification

GMP knowledge

ISO 13485

Drawings interpretation

Power BI

Excel

Python

Bioburden testing

TOC testing

Education

Bachelor’s degree in engineering, Science, or related technical discipline

Tools

Minitab

Power BI

Excel

Python

Job description

Globus Medical is seeking a Quality Engineer to support musculoskeletal devices and instruments manufacturing. The role drives quality systems improvement, CAPA, and supplier quality in a regulated medical device environment.

You will work with cross-functional teams to resolve quality issues, validate processes, and ensure compliance with GMP, ISO 13485, and FDA QMSR. Collaboration across sites and leadership communication are essential.