Engineer I, Quality

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.; Singapore; On-site; SGD 45,000 - 75,000; Full time

Benefits offered by this job

Annual incentive plans

Career development

Collaborative environment

Job summary

Thermo Fisher Scientific in Singapore is seeking an Engineer I, Quality Assurance to join the Quality organization supporting the Genetic Sciences business. You will help ensure products consistently meet customer expectations, regulatory requirements, and quality standards throughout the product lifecycle.

You will investigate quality issues, support continuous improvement initiatives, and contribute to maintaining compliance in a regulated manufacturing environment.

Qualifications

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

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.

Skills

Analytical thinking

Problem-solving

Organizational skills

Written & verbal communication

Team collaboration

Independent work

Education

Bachelor's degree in Mechanical Engineering, Electronics Engineering, or related Engineering discipline

Tools

TrackWise

Microsoft Office

Job description

Engineer I, Quality Assurance (QA)

Location: Block 33 Marsiling Industrial Estate Road 3, Singapore

Work Schedule

Standard (Monday to Friday) 8:00am to 5:15pm

Environmental Conditions

Office and Manufacturing Environment

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day to enable our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources, training, and opportunities to achieve their career goals while helping solve some of the world's toughest scientific and healthcare challenges.

As an Engineer I, Quality Assurance, you will be part of the Quality organization supporting the Genetic Sciences business. You will help ensure products consistently meet customer expectations, regulatory requirements, and quality standards throughout the product lifecycle. Working closely with Manufacturing, Engineering, Operations, and cross-functional teams, you will investigate quality issues, support continuous improvement initiatives, and contribute to maintaining compliance in a regulated manufacturing environment.

Key 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.

Minimum Qualifications

• Bachelor's degree in Mechanical Engineering, Electronics Engineering, or another related Engineering discipline.

• No prior experience required. Internship or industry experience in Medical Device, Pharmaceutical, Life Sciences, or regulated manufacturing environments is an advantage.

• Basic understanding of Good Manufacturing Practices (GMP/cGMP), Quality Management Systems, and international quality standards is preferred.

• Strong analytical, problem-solving, and organizational skills.

• Good written and verbal communication skills.

• Ability to work independently while collaborating effectively with cross-functional teams.

• Proficient in Microsoft Office applications.

Preferred Qualifications

• Exposure to quality tools such as CAPA (Corrective and Preventive Action), Root Cause Analysis, Failure Analysis, Change Control, or Risk Management (PFMEA).

• Familiarity with electronic Quality Management Systems (e.g., TrackWise) is an advantage.

• Knowledge of medical device or life sciences regulations is preferred.

Benefits

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.