Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
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.
Performs statistical analysis and works with manufacturing to investigate, conduct root cause analysis, recommend corrective actions for processes and products and to contribute to and track data to support site level performance to KPIs (e.g. yield improvements, CAPA, complaint and scrap reduction). Those activities include the planning, development and support of processes, procedures and test plans in order to ensure that products manufactured meet internal, customer and regulatory requirements
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 9001:2015, 21 CFR Part 820, 21 CFR Part 211
• 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
• Designee for QE Manager as required including attending meetings, participating in customer audits, represent QE team at technical visits and on customer calls.
• Strategically planning across the network supporting AQP establishment/strengthening the QE teams as one global network teams.
• Support the site change control system including process risk assessment in the form of FMEA tools.
• Works directly with customers on complex critical quality issues/complaints. Leads issue/complaint resolution.
