Engineer III, QA

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

Are you an experienced Engineer looking for a unique opportunity to make a significant impact? Look no further! Thermo Fisher Scientific Inc. is seeking an Engineer III, QA with a proven track record of impactful contributions to join our world-class team in Middletown.

Responsibilities:

• Determine and implement quality assurance procedures, processes, and standards
• Collaborate with various teams to ensure flawless execution of quality control activities
• Conduct rigorous testing and analysis to identify areas for improvement and optimization
• Monitor and collaborate with team members for daily operational compliance to the quality management system (QMS) and other Regulatory, ISO, and international standards.
• Improve product and process quality through direct support and monitoring of value stream production and new development.
• Lead and support the investigation of nonconformance, audit findings, CAPA's, complaints, environmental alerts and SCAR's by conducting CAPA investigations, risk assessment (FMEA, DFMEA, PFMEA), root cause analysis and effectivity checks.
• Assist with the preparation and approval of change control documents related to the operation and improvement of Operations processes.
• Compete in a fast-paced environment to meet strict deadlines
• Conduct internal and participate in external Quality System audits to assess the compliance with the QMS, FDA regulations, ISO standards, EU IVDR and any other international regulations and internal requirements.
• Successfully implement continuous improvement initiatives to enhance overall quality and efficiency

• Bachelor's degree in Engineering or a related field, or equivalent experience
• Proven experience in quality assurance within an engineering role
• Extensive understanding of quality control methods and effective approaches
• Exceptional problem-solving and analytical skills
• Understanding of global regulatory and quality requirements associated with medical devices such as ISO 13485, ISO 14971, 21 CFR Part 820
• Knowledge of IVDR and MDR, a plus.
• Experience working in a liquid formulation and fill operation, a plus
• ASQ certified quality engineer, ASQ certified quality auditor, and/or Six Sigma/Lean certified, a plus
• Excellent communication and collaboration abilities