Thermo Fisher Scientific - Middletown, VA
posted 6 months ago
About the position
Thermo Fisher Scientific Inc. is seeking an experienced Engineer III, QA to join our world-class team in Middletown, Virginia. This role is pivotal for ensuring that our products meet the highest quality standards and regulatory requirements. As an Engineer III, you will be responsible for determining and implementing quality assurance procedures, processes, and standards that align with Good Manufacturing Practices (GMP) and other regulatory guidelines. You will collaborate with various teams to ensure flawless execution of quality control activities, conducting rigorous testing and analysis to identify areas for improvement and optimization. In this position, you will monitor and collaborate with team members to ensure daily operations comply with the quality management system (QMS) and other regulatory, ISO, and international standards. Your efforts will directly contribute to improving product and process quality through support and monitoring of value stream production and new development initiatives. You will lead and support investigations of nonconformance, audit findings, and corrective actions by conducting CAPA investigations, risk assessments, root cause analysis, and effectiveness checks. Additionally, you will assist with the preparation and approval of change control documents related to operational improvements. The role requires you to thrive in a fast-paced environment, meeting strict deadlines while conducting internal and participating in external Quality System audits to assess compliance with QMS, FDA regulations, ISO standards, and other international regulations. Your successful implementation of continuous improvement initiatives will enhance overall quality and efficiency within the organization.
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 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
Requirements
- 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
Nice-to-haves
- Knowledge of IVDR and MDR
- Experience working in a liquid formulation and fill operation
- ASQ certified quality engineer
- ASQ certified quality auditor
- Six Sigma/Lean certified
