Quality Engineer (Medical Devices)

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

. @@HD@@ Key Responsibilities@@/HD@@ @@HD@@ • Support and maintain the Quality Management System (QMS)@@/HD@@ in compliance with

and regulatory requirements. • Lead and support

investigations, root cause analysis, and effectiveness checks. • Perform

, and support external regulatory audits (FDA, notified bodies). • Review and approve

, including DHF (Design History File), DMR (Device Master Record), and DHR (Device History Record). • Participate in

(ISO 14971), including hazard analysis, FMEA, and risk control implementation. • Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs) for

. • Ensure compliance with

and quality standards. • Handle

and lead investigations for product or process deviations. • Support

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

, including qualification, monitoring, and performance evaluation. • Analyze quality data and implement

(Lean, Six Sigma).

. • Strong working knowledge of: •

•

•

•

. • Familiarity with

and quality methodologies (SPC, Six Sigma, Root Cause Analysis). • Excellent problem-solving, analytical, and communication skills.

will added advantage • Experience with

. • Knowledge of

. • Experience in HLA (and

SMT

• Attention to detail and compliance mindset • Strong analytical and investigative skills • Cross-functional collaboration • Effective communication and documentation • Continuous improvement mindset

• Office and manufacturing floor interaction • May require participation in audits, inspections, and supplier visits

• 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, age, disability, genetic information, veteran status, or any other characteristic protected by law. 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. @@HD@@ Accommodation Statement@@/HD@@ 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.