6705 - Quality Engineer(Medical Device)

Job Description:

• Provide quality oversight to ensure manufacturing activities comply with internal quality systems, applicable regulatory requirements, and customer expectations.
• Support process and equipment validation activities, including review of validation protocols, reports, controls, and data integrity.
• Lead or support investigation of quality issues using structured root cause analysis (RCA) methodologies and drive effective corrective and preventive actions (CAPA).
• Prepare, review, and approve quality documentation such as control plans, inspection procedures, validation documents, and related records.
• Collaborate with manufacturing teams to support continuous improvement initiatives while ensuring product quality and compliance are maintained.
• Support supplier and component quality activities, including evaluation of supplier performance and quality-related issues, where applicable.
• Support post-market surveillance (PMS) activities by investigating complaints, identifying trends, and translating findings into preventive and improvement actions.
• Support internal and external audits to ensure effective implementation of quality systems at the manufacturing site.
• Communicate quality requirements clearly to manufacturing personnel and escalate quality risks or non-conformances as required.
• Participate in Lean, Kaizen, and other quality or process improvement initiatives with cross-functional teams.

Requirements:

• Bachelors degree in Engineering (Manufacturing, Materials, Biomedical, or a related discipline).

• Strong verbal and written communication skills with good proficiency in English.

• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook, and related tools).