Engineer I, Quality Assurance (QA)

About the Role

Join Thermo Fisher Scientific as an Engineer I in Quality Assurance at our Marsiling site, where your work will directly support advances in genetic sciences by maintaining compliance and excellence in product quality. Working in both an office and manufacturing environment, you'll play a pivotal role in ensuring products align with customer needs, all relevant regulations, and rigorous internal standards throughout product development and production.

Key Responsibilities

• Promptly review and handle customer complaints, documenting details and escalating issues in the TrackWise quality management system.
• Investigate and resolve customer and manufacturing quality concerns, performing root cause analysis and collaborating with various teams for resolution.
• Conduct failure analyses on returned products, coordinating with engineering teams to address issues.
• Contribute to product qualification by validating that protocols and reports meet standards, and support new product introductions and transfers as a QA representative.
• Manage Return Material Authorizations (RMAs) and ensure products are returned for proper failure analysis within specified timeframes.
• Review, approve, and maintain quality records such as change orders, deviations, Device Master Record Index (DMRI), and PFMEA documentation.
• Monitor and analyze product quality trends, offering actionable insights for ongoing quality improvement.
• Prepare essential export and compliance documents like Certificates of Analysis (COA), Certificates of Conformance (COC), and Country of Origin (COO) paperwork as needed.
• Participate in internal audits, quality initiatives, and continuous improvement programs across the plant to enhance processes and reduce risks.
• Ensure all activities comply with quality and regulatory requirements, including cGMP, ISO 13485, ISO 9001, FDA 21 CFR 820, MDSAP, IVDR, ISO 14001, and ISO 45001.
• Undertake various other quality-related responsibilities or special projects as assigned.

Requirements

• Bachelor’s degree in Mechanical Engineering, Electronics Engineering, or related engineering field.
• No previous full-time experience is required, but internships or exposure to medical device, pharmaceuticals, life sciences, or regulated manufacturing industries will be advantageous.
• Basic knowledge of Good Manufacturing Practices (GMP/cGMP), Quality Management Systems, and relevant international standards is helpful.
• Analytical mindset, strong organizational abilities, and effective problem-solving capabilities.
• Clear written and verbal communication skills.
• Comfortable working independently as well as collaboratively within multidisciplinary teams.
• Proficiency with Microsoft Office suite.

Preferred Qualifications

• Familiarity with quality tools such as CAPA, Root Cause Analysis, Failure Analysis, Change Control, or Risk Management (PFMEA).
• Experience with electronic Quality Management Systems such as TrackWise is a plus.
• Awareness of medical device or life sciences regulations.

Working Hours & Environment

• Standard schedule is Monday to Friday, 8:00 am to 5:15 pm.
• Work is conducted in an office and regulated manufacturing setting.

Benefits

• Competitive compensation and incentive programs.
• Ongoing career development resources and opportunities.
• Collaborative, supportive workplace culture focused on scientific advancement and positive global impact.