Job Summary

We are seeking a detail-oriented Quality Engineer with experience in the medical 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 as ISO 13485, FDA QSR (21 CFR Part 820), and GMP.

Key Responsibilities

• Support and maintain the Quality Management System (QMS) in compliance with ISO 13485 and regulatory requirements.
• Lead and support CAPA (Corrective and Preventive Actions) investigations, root cause analysis, and effectiveness checks.
• Perform Internal Audits, Supplier Audits, and support external regulatory audits (FDA, notified bodies).
• Review and approve design documentation, including DHF (Design History File), DMR (Device Master Record), and DHR (Device History Record).
• Participate in risk management activities (ISO 14971), including hazard analysis, FMEA, and risk control implementation.
• Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs) for new product development and process validation.
• Ensure compliance with Good Manufacturing Practices (GMP) and quality standards.
• Handle non-conformance reports (NCR) and lead investigations for product or process deviations.
• Support validation activities (IQ/OQ/PQ, software validation, process validation).
• Drive supplier quality management, including qualification, monitoring, and performance evaluation.
• Analyze quality data and implement continuous improvement initiatives (Lean, Six Sigma).

Required Qualifications

• Bachelor’s degree in Engineering, Biomedical, Life Sciences, or related field.
• 3–8 years of experience in quality engineering within the medical device/pharmaceutical/healthcare industry.
• Strong working knowledge of:
  • ISO 13485
  • FDA 21 CFR Part 820
  • ISO 14971 (Risk Management)
  • GMP requirements
• Experience with CAPA, audits, validation, and document control systems.
• Familiarity with statistical tools and quality methodologies (SPC, Six Sigma, Root Cause Analysis).
• Excellent problem-solving, analytical, and communication skills.

Preferred Qualifications

• Certification such as Certified Quality Engineer (CQE) or Six Sigma Green Belt/Black Belt will added advantage
• Experience with sterile products, combination products, or Class II/III medical devices.
• Knowledge of regulatory submissions (e.g., 510(k), CE Marking).
• Experience with electronic QMS systems
• Experience in supplier quality management.
• Experience in HLA (and High 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

BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact your local police department. Any scam job listings should be reported to whatever website it was posted in.

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

Accommodation Statement

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.