Senior Quality Engineer, Manufacturing Transfer (Malaysia)

Medtronic plc; Kulim; Vor Ort; MYR 120.000 - 210.000; Vollzeit

Zusammenfassung

Medtronic plc in Malaysia invites applications for a Senior Quality Engineer to drive transfer of manufacturing processes to a new site. You will ensure ISO 13485 compliance and coordinate cross-functional teams across design, engineering, and supply chain.

Based on-site in Kulim, this role requires strong technical judgment, GMP knowledge, and willingness to travel for project transfers. You will mentor junior engineers and contribute to a robust QMS as part of a global team.

Qualifikationen

• Degree in engineering and at least 6 years of relevant experience.
• Experience in regulated industries (medical devices/pharma/biotech).
• Experience drafting and reviewing technical docs (protocols, reports, validations).
• Knowledge of ISO 13485 requirements.
• Good GMP understanding.
• Intermediate to advanced English, reading and writing technical documents.
• Clear verbal and written communication abilities; travel willingness.

Aufgaben

• Provide technical guidance to junior quality engineers during transfer.
• Develop and maintain quality standards for transferring products and processes per ISO 13485 and QMS.
• Collaborate with cross-functional teams to integrate quality requirements throughout transfer.
• Define inspection methods, sampling plans, and controls for transferred processes.
• Support TMV, IQ/OQ/PQ, and ensure regulatory and QMS compliance.
• Maintain risk management docs (PFMEA, control plans) for transfer and ramp-up.
• Coordinate readiness of equipment and tooling for qualification and start-up.
• Review nonconformances and drive CAPA closure.
• Maintain audit-ready records and support regulatory audits.

Kenntnisse

Quality engineering

ISO 13485

GMP knowledge

English (technical)

Ausbildung

Engineering degree

Jobbeschreibung

Medtronic plc in Malaysia invites applications for a Senior Quality Engineer to drive transfer of manufacturing processes to a new site. You will ensure ISO 13485 compliance and coordinate cross-functional teams across design, engineering, and supply chain.

Based on-site in Kulim, this role requires strong technical judgment, GMP knowledge, and willingness to travel for project transfers. You will mentor junior engineers and contribute to a robust QMS as part of a global team.