Engineer II, QA

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.

DESCRIPTION:
Join Thermo Fisher Scientific's Quality Assurance team and contribute to our mission to make the world healthier, cleaner and safer. As a Quality Engineer II, you will ensure compliance with quality standards and regulatory requirements across our manufacturing operations. You'll collaborate with cross-functional teams to drive continuous improvement initiatives, lead investigations, and implement corrective actions to maintain our high standards of product quality. This role offers exposure to innovative technologies and the opportunity to directly impact patient care through quality oversight of critical products.

RESPONSIBILITIES

• Retrieve complaints from various database and update complaint log.

• Review and process complaints in a uniform and timely manner.

• Review technical complaint threshold report and initiate escalated complaint(s) from various databased into Trackwise System.

• Lead in the resolution of customer complaint and quality issues on manufacturing floor to provide voice of customers to operations and translate customer's feedback into innovative solutions.

• Identify and establish incoming and outgoing Product QC inspection criteria and provide training to QC Technicians.

• Participate in Product Qualification activities by reviewing test protocols and reports to ensure product quality meet the specified requirements.

• Issue RMA (Return Material Authorization) for units that requires to be returned for FA (Failure Analysis) and ensure it returns for FA.

• Perform failure analysis on product failures and work with Engineering to resolve product faults.

• Establish DMRI (Device Master Record Index).

• Review change orders, deviation and risk management for products.

• Provide management with quality data and trends in product performance in meeting customer requirements.

• Participate in internal audits to ensure the effective implementation of Quality Management System.

• Act as Operation QA Representative for NPI (New Product Introduction) project and Transfer project.

• Act as customer representative, attend to customer enquires/ feedback, assist in customer visit, coordinate, and lead the team in customer audits.

• Lead in quality initiatives program to address system inadequacies which may include quality programs, tracking, analyzing, reporting and problem solving to achieve continual quality improvement objectives.

• Supports company goals and objectives, policies, and procedures in compliance with quality systems, cGMP and FDA regulations.

• Ensure that systems and procedures are in compliance with ISO13485, MDSAP, FDA 21CFR Part 820, IVDR, ISO9001, ISO14001 and ISO45001 requirement.

• Support plant-wide activities and special projects, as assigned.

REQUIREMENTS:

• Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of quality assurance experience in GMP/ISO regulated environments, preferably in medical devices, pharmaceuticals or biotechnology

• Preferred Fields of Study: Life Sciences, Engineering, Chemistry or related scientific/technical field

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

• 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, Work Instructions and reports

• Strong proficiency in quality management software (TrackWise, SAP QM, 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

• Project management skills and ability to prioritize effectively