Senior Quality Engineer
Detail posisi
Kewajiban
• Reviews regulatory, QMS and customer requirements to ensure compliance and meet the requirements.
• Ensure the quality of product and process to meet with the regulation and customer’s requirement.
• Maintain audit programs and Management review and provide reporting results to management.
• Participates in internal, external, customer audits (and regulatory inspections).
• Maintain Complaint file and Corrective action & Preventive action system.
• Maintain Process Validation activities.
• Facilitate communication between functions, multi-facility groups and customers.
• Resource review.
• Pursue team in organization for Continuous improvement.
Kualifikasi
• Bachelor degree or higher in Engineering field or equivalent industry experience.
• A minimum of 10 years of experience in the Quality function.
• Experience for both of Quality Assurance engineer (In process/product and customer quality) and Quality Management System in electronics manufacturing.
• Experience in PCBA or complete medical device will be advantageous.
• Knowledge of FDA Quality System Requirements 21CFR820, 21CFR PART11, ISO 13485, ISO 14971 and Medical Process validation IQOQPQ will be advantageous.
• Ability to manage small projects/programs with limited assistance from others.
• Certified Internal Auditor.
• Ability to use Microsoft Office and email.
• Leadership skills including ability to maintain confidentiality.
• Knowledge and ability to be a consultant of Corrective action & Preventive action program base on 8D methodologies.
• Ability for communication, teamwork and organizational skills to carry out projects to meet timelines.
• Decision making and prioritization skills.
• Good English communication.