Engineer I, QA (Marsiling)

Work Schedule

Environmental Conditions

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 youll 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 worlds 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

• Bachelors 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 youll be empowered to grow your career while working alongside colleagues who are passionate about advancing science and improving lives worldwide.

Apply today! Join our global team and help us enable our customers to make the world healthier cleaner and safer.