Job Description

Locations

• Singapore, Singapore
• Singapore, Marsiling

Skills Required

• Medical Deviceintermediate
• Microsoft Office applicationsintermediate
• electronic Quality Management Systemsintermediate
• medical deviceintermediate

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Electronics Engineering, or another related Engineering discipline. (degree in mechanical engineering)
• No prior experience required. Internship or industry experience in Medical Device, Pharmaceutical, Life Sciences, or regulated manufacturing environments is an advantage. (experience)
• Basic understanding of Good Manufacturing Practices (GMP/cGMP), Quality Management Systems, and international quality standards is preferred. (experience)
• Strong analytical, problem-solving, and organizational skills. (experience)
• Good written and verbal communication skills. (experience)
• Ability to work independently while collaborating effectively with cross-functional teams. (experience)
• Proficient in Microsoft Office applications. (experience)
• Bachelor's degree in Mechanical Engineering, Electronics Engineering, or another related Engineering discipline. (degree in mechanical engineering)
• No prior experience required. Internship or industry experience in Medical Device, Pharmaceutical, Life Sciences, or regulated manufacturing environments is an advantage. (experience)
• Basic understanding of Good Manufacturing Practices (GMP/cGMP), Quality Management Systems, and international quality standards is preferred. (experience)
• Strong analytical, problem-solving, and organizational skills. (experience)
• Good written and verbal communication skills. (experience)
• Ability to work independently while collaborating effectively with cross-functional teams. (experience)
• Proficient in Microsoft Office applications. (experience)

Preferred Qualifications

• Exposure to quality tools such as CAPA (Corrective and Preventive Action), Root Cause Analysis, Failure Analysis, Change Control, or Risk Management (PFMEA). (experience)
• Familiarity with electronic Quality Management Systems (e.g., TrackWise) is an advantage. (experience)
• Knowledge of medical device or life sciences regulations is preferred. (experience)
• Exposure to quality tools such as CAPA (Corrective and Preventive Action), Root Cause Analysis, Failure Analysis, Change Control, or Risk Management (PFMEA). (experience)
• Familiarity with electronic Quality Management Systems (e.g., TrackWise) is an advantage. (experience)
• Knowledge of medical device or life sciences regulations is preferred. (experience)

Responsibilities

• Review, process, and manage customer complaints in a timely and consistent manner.
• Maintain complaint records and initiate complaint escalations through the TrackWise quality management system.
• Lead investigations into customer complaints and manufacturing quality issues, identifying root causes and driving effective resolution.
• Perform failure analysis on returned products and collaborate with Engineering teams to resolve product issues.
• Support Product Qualification activities by reviewing validation protocols and reports to ensure products meet quality requirements.
• Coordinate Return Material Authorizations (RMA) and ensure timely return of products for Failure Analysis (FA).
• Review and approve quality documentation, including change orders, deviations, Device Master Record Index (DMRI), and Process Failure Mode and Effects Analysis (PFMEA).
• Support New Product Introduction (NPI) and product transfer projects as the Quality Assurance representative.
• Analyze product quality trends and provide recommendations for continuous improvement.
• Prepare Certificates of Analysis (COA), Certificates of Conformance (COC), and Country of Origin (COO) documentation when required.
• Support quality initiatives, internal audits, and plant-wide continuous improvement activities.
• Ensure compliance with applicable quality systems and regulatory requirements, including cGMP, ISO 13485, ISO 9001, FDA 21 CFR Part 820, MDSAP, IVDR, ISO 14001, and ISO 45001.
• Perform other quality-related duties and special projects as assigned.
• Review, process, and manage customer complaints in a timely and consistent manner.
• Maintain complaint records and initiate complaint escalations through the TrackWise quality management system.
• Lead investigations into customer complaints and manufacturing quality issues, identifying root causes and driving effective resolution.
• Perform failure analysis on returned products and collaborate with Engineering teams to resolve product issues.
• Support Product Qualification activities by reviewing validation protocols and reports to ensure products meet quality requirements.
• Coordinate Return Material Authorizations (RMA) and ensure timely return of products for Failure Analysis (FA).
• Review and approve quality documentation, including change orders, deviations, Device Master Record Index (DMRI), and Process Failure Mode and Effects Analysis (PFMEA).
• Support New Product Introduction (NPI) and product transfer projects as the Quality Assurance representative.
• Analyze product quality trends and provide recommendations for continuous improvement.
• Prepare Certificates of Analysis (COA), Certificates of Conformance (COC), and Country of Origin (COO) documentation when required.
• Support quality initiatives, internal audits, and plant-wide continuous improvement activities.
• Ensure compliance with applicable quality systems and regulatory requirements, including cGMP, ISO 13485, ISO 9001, FDA 21 CFR Part 820, MDSAP, IVDR, ISO 14001, and ISO 45001.
• Perform other quality-related duties and special projects as assigned.

Benefits

• general: We offer competitive remuneration, annual incentive plans, career development opportunities, and a collaborative work environment where your contributions help make a meaningful difference. At Thermo Fisher Scientific, you'll be empowered to grow your career while working alongside colleagues who are passionate about advancing science and improving lives worldwide.
• general: Apply today! Join our global team and help us enable our customers to make the world healthier, cleaner, and safer.

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