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.

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!

Visit the site: Middletown Matters - YouTube

Listen to one of our colleagues: https://www.youtube.com/watch?v=klAVrUJqfVc

Find out more about Thermo Fisher: https://www.youtube.com/watch?v=zPVv85C6XSE

What will you do:

• 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.

How will you get here?

• Bachelor’s degree in Science or Engineering or related subject area preferred
• 4+ years quality engineering experience with a medical device company.
• Experience working in a liquid formulation and fill operation, a plus.
• Working knowledge of global regulatory and quality requirements associated with medical devices such as ISO 13485, ISO 14971, 21 CFR Part 820
• Working knowledge of IVDR and MDR, a plus.
• Experience in formal problem solving in a team environment.
• Ability to work independently and to collaborate effectively in interdisciplinary teams.
• Detail oriented and can lead multiple projects and activities assigned.
• Excellent organizational skills, planning, communication and follow-up skills.
• ASQ certified quality engineer, ASQ certified quality auditor, and/or Six Sigma/Lean certified, a plus.
• Proficient in Microsoft Word, PowerPoint, and Excel

Physical Requirements

• Normal office and manufacturing environment.
• Position will require frequent communication with and walking to other areas which designated PPE will be required.
• Position will require prolonged sitting and standing.
• Employee may occasionally lift and/or move up to 25 pounds.

Benefits include 401k, healthcare and vision coverage, employee assistance program, 24/7 virtual doctor visits, back up children and eldercare, and more!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may