Engineer II, Quality

Job Description :

Work Schedule

Environmental Conditions

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.

REQUIREMENTS:
. 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
. 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

. Responsible to oversees non-conformance material (NCM) process to ensure the NCM Trackwise Problem Report (PR) is closed on timely manner.

. Review and approves Part Qualification Packages (first article report, engineering drawing, RoHS declaration, etc) and Supplier Change Request package for any change request initiated by supplier.

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