Manager Quality Engineer

at  Thermo Fisher Scientific

JOB DESCRIPTION

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!
The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select IVD market segments and has been a trusted supplier in the IVD industry for over 40 years. The division provides products for drugs of abuse testing, therapeutic drug monitoring, quality control, sepsis diagnosis, prenatal screening and more. Additionally, the division provides advanced laboratory instrumentation and high-throughput laboratory automation equipment for use in a variety of laboratory settings. Products are offered through direct sales, regional distributors, and OEM partnerships.
At our Middletown site 500+ colleagues produce over 10 billion tests annually through custom, contract and OEM businesses for Hematology, Hemostasis, Clinical Chemistry, Immunoassay and Molecular.

• Improve product and process quality through direct support and monitoring of value stream production and new development.
• Monitor and collaborate with stakeholders for daily operational compliance to the quality management system (QMS) and other Regulatory, ISO, and international standards.
• Provide quality guidance, support, and leadership in the design, development, and design transfer processes for new product/service development projects; collaborating with other project team members and other stakeholders to evaluate established requirements and determine measures necessary for the implementation of programs.
• Contribute to the ongoing development and continuous improvement of requirement management, risk management, design and development, design transfer, change management, defect management, supplier quality, and quality management system (QMS) related procedures and processes.
• Assist in training, implementation, and maintaining compliance to regulations and procedures.
• 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.
• Drive continuous quality improvement in processes.
• Provide support in responding to customer requests for documentation, data, investigations, risk assessments and testing.
• Participation as team member on customer-facing projects
• 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.