Med Device Quality Engineer: Process & CAPA Lead

NML Medical; Limerick (Montgomery County); On-site; USD 75,000 - 110,000; Full time

Job summary

Globus Medical, Inc. in Limerick, PA, is seeking a Quality Engineer to support musculoskeletal device manufacturing through quality systems development, validation, and continuous improvement.

You will work with cross-functional teams to apply statistical analysis and risk-based decision-making to resolve quality issues and support process validation and QMS compliance. The role emphasizes CAPA, suppliers quality, audits, and data-driven improvements, with a focus on GMP/ISO 13485, FDA QMSR, and

Qualifications

• Bachelor’s degree in engineering, science, or related STEM field.
• 2–4 years of experience in Quality/Manufacturing Engineering or QA.
• Experience in medical device manufacturing or regulated industry preferred.
• Knowledge of SPC, MSA, DOEs, Six Sigma, and process capability.
• Familiarity with GMP, ISO 13485, FDA QMSR.
• Proficiency with Excel; Power BI or similar; Python is a plus.
• Strong analytical, communication, and cross-functional collaboration.
• Support audits and maintain quality management system procedures.

Responsibilities

• Investigate and resolve product, process, and systems quality issues (NCs or deviations).
• Analyze manufacturing data to evaluate process performance and improve quality and efficiency.
• Own supplier quality, SCARs, supplier audits, and supplier qualifications.
• Lead CAPA activities with root-cause analysis and verification of effectiveness.
• Develop and validate manufacturing processes (IQ/OQ/PQ) and MVPs.
• Participate in risk management (PFMEA) and control plan maintenance.
• Support internal/external audits and maintain quality documentation.
• Communicate findings and project updates to teams and leadership.

Skills

Quality engineering

Manufacturing engineering

Quality assurance

Statistical methods

GMP/ISO 13485

Minitab

Lean manufacturing

Education

Bachelor’s degree in engineering or related STEM field

Tools

Minitab

Power BI

Excel

Python (basic)

Job description

Globus Medical, Inc. in Limerick, PA, is seeking a Quality Engineer to support musculoskeletal device manufacturing through quality systems development, validation, and continuous improvement.

You will work with cross-functional teams to apply statistical analysis and risk-based decision-making to resolve quality issues and support process validation and QMS compliance. The role emphasizes CAPA, suppliers quality, audits, and data-driven improvements, with a focus on GMP/ISO 13485, FDA QMSR, and