Quality Engineer (Medical Devices)

Job Summary

We are seeking a detail-orientedQuality Engineer with experience in themedical device or healthcare products industry to ensure compliance with regulatory standards and drive continuous improvement in product quality and manufacturing processes. The ideal candidate will have strong knowledge of quality systems, risk management, and regulatory requirements such asISO 13485, FDA QSR (21 CFR Part 820), and GMP.

Key Responsibilities

• Support and maintain theQuality Management System (QMS) in compliance withISO 13485 and regulatory requirements.

• Lead and supportCAPA (Corrective and Preventive Actions) investigations, root cause analysis, and effectiveness checks.

• PerformInternal Audits, Supplier Audits, and support external regulatory audits (FDA, notified bodies).

• Review and approvedesign documentation, including DHF (Design History File), DMR (Device Master Record), and DHR (Device History Record).

• Participate inrisk management activities (ISO 14971), including hazard analysis, FMEA, and risk control implementation.

• Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs) fornew product development and process validation.

• Ensure compliance withGood Manufacturing Practices (GMP) and quality standards.

• Handlenon-conformance reports (NCR) and lead investigations for product or process deviations.

• Supportvalidation activities (IQ/OQ/PQ, software validation, process validation).

• Drivesupplier quality management, including qualification, monitoring, and performance evaluation.

• Analyze quality data and implementcontinuous improvement initiatives (Lean, Six Sigma).

Required Qualifications

• Bachelor’s degree inEngineering, Biomedical, Life Sciences, or related field.

• 3–8 years of experience in quality engineering within themedical device/pharmaceutical/healthcare industry.

• Strong working knowledge of:

  • ISO 13485

  • FDA 21 CFR Part 820

  • ISO 14971 (Risk Management)

  • GMP requirements

• Experience withCAPA, audits, validation, and document control systems.

• Familiarity withstatistical tools and quality methodologies (SPC, Six Sigma, Root Cause Analysis).

• Excellent problem-solving, analytical, and communication skills.

Preferred Qualifications

• Certification such asCertified Quality Engineer (CQE) orSix Sigma Green Belt/Black Belt will added advantage

• Experience withsterile products, combination products, or Class II/III medical devices.

• Knowledge ofregulatory submissions (e.g., 510(k), CE Marking).

• Experience with electronic QMS systems

• Experience insupplier quality management.

• Experience in HLA (andHigh Level Assembly Manufacturing) SMT(PCBA manufacturing)

Key Competencies

• Attention to detail and compliance mindset

• Strong analytical and investigative skills

• Cross-functional collaboration

• Effective communication and documentation

• Continuous improvement mindset

Work Environment

• Office and manufacturing floor interaction

• May require participation in audits, inspections, and supplier visits

Example KPIs

• CAPA closure timelines

• Audit findings and compliance scores

• Reduction in non-conformances

• Process improvement metrics

• Supplier quality performance

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.

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