Engineer III, QA (Senior Quality Assurance Engineer)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Position Summary:

The Engineer III, QA plays a critical role in driving quality excellence across the Asia Distribution Centre (ADC) and Global Repair Centre (GRC). This position is responsible for leading and implementing quality initiatives to address system inadequacies, ensuring compliance with global standards, and fostering continual improvement in processes and products.

Key Responsibilities:

Participate in the development and implementation of quality initiatives to address system inadequacies in Asia Distribution Centre (ADC) and Global Repair Centre (GRC) to achieve compliance and continual quality improvement objectives.

Leads and carry out quality initiatives program to address system inadequacies in ADC and GRC, this may include participating in quality programs, tracking, analyzing, reporting and problem solving. Examples: investigation report, CAPA Plan, Containment Action Report, Risk Management Plan, etc.

Build quality into products through active participation with cross functional teams in ADC and GRC projects and processes to support product release:

a) Assist with new line/cell to be set-up at GRC.

b) Lead and evaluate cold storage testing, validation protocol with warehouse supervisors.

c) Lead and drive resolution on product damages with transportation supervisors.

d) Develop temperature excursion management strategies

Supports company goals and objectives, policies and procedures in compliance with quality systems, cGMP, FDA 21 CFR Part 820, ISO14001 and ISO4500 requirements.

Participate and carry out systems and procedures are compliance with ISO9001, ISO14001, ISO13485, ISO14971, FDA 21CFR Part 820, ISO 45001 and Medical Device Single Audit Program (MDSAP). Ensure regulatory readiness for audits and inspections.

Support plant-wide activities and special projects as assigned.

Drive improvement of processes of the quality system and apply professional tools to solve complex problems.

Champion Practical Process Improvement (PPI) to ensure compliance and improve customer satisfaction.

Manage escalation through to resolutions.

Mentor junior Quality Engineer and Quality Technician.

REQUIREMENTS:

Bachelor's Degree in Engineering (Mechanical or Electronics) or Degree in Science (Biology, Chemistry, Bio-engineering.) plus 8 years of quality assurance experience in GMP/ISO regulated environments in cold chain logistics & distribution quality, preferably in medical devices, pharmaceuticals or biotechnology

Strong knowledge of quality systems, cGMP regulations, and standards including ISO 13485, 21 CFR Part 820

Trained in specific standards (ISO 9001, ISO13485, MDSAP, ISO 14971, Good Distribution Practices, etc.

Trained in quality tools (8 disciplines of problem solving (8D), Failure Modes and Effect analysis (FMEA), etc. -

Trained as Internal Auditor.

Experience in process validation activities for cold chain distribution/warehouse.

Expertise in quality tools and methodologies including risk management, root cause analysis, CAPA, and change control

Demonstrated experience leading investigations, analyzing quality data, and implementing effective corrective actions

Excellent documentation and technical writing skills for developing SOPs, protocols and reports

Proficiency in quality management software (TrackWise, SAP, E1 etc.) and Microsoft Office suite

Experience conducting internal audits and supporting external regulatory inspections

Demonstrated ability to build consensus and collaborate across functions

Strong verbal and written communication skills

Ability to work independently while contributing effectively in team environments

Strong attention to detail with analytical and problem-solving capabilities

Experience with statistical analysis tools and quality metrics reporting