QA Engineer (Product Quality)

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.

RESPONSIBILITIES:

• Ensure compliance with quality standards and regulatory requirements across our manufacturing operations.

• Collaborate with cross-functional teams to drive continuous improvement initiatives, lead investigations, and implement corrective actions to maintain our high standards of product quality.

• Manage end-to-end complaint handling, including complaint review, escalation, failure analysis, customer communication, trend reporting, and resolution of product and transportation-related quality issues.

• Establish and maintain product quality controls, support product qualification, NPI and transfer projects, supplier quality, MRB, change control, deviations, risk management, audits, and continuous improvement initiatives.

• Ensure that quality systems and operations comply with applicable company procedures, cGMP, FDA requirements, ISO 13485, MDSAP, IVDR, ISO 9001, ISO 14001, ISO 45001, and other relevant regulatory standards.

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

• ISO 13485/FDA Lead Auditor certification beneficial

• ASQ certification (CQE, CQA) advantageous

• 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, protocols 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

• Ability to work in clean room environments when required