NCR Analyst

Location/Division Specific Information

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.

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

How you will make an impact:

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

Position Summary:

• Responsible for the operation, implementation, and maintenance of the nonconformance (NCR) system, which also includes discrepancy reports (DRS). Chairs or participates in the Material Review Board to drive the timely resolution and closure of NCRs and DRs. Maintains and reports status of NCRs and DRs.
• Assesses NCR and DR input to ensure compliant, meaningful information and necessary data are included in the report (completeness of description, evaluation, and adequate justification for final disposition of material).
• Supports the VS Manager, Quality Engineer or Scientist in investigating nonconformances or discrepancies, identifying the primary root causes using established problem-solving methodologies (Root Cause Analysis, Mistake-Proofing, etc.) and determining appropriate corrective and preventive actions by providing information needed to resolve customer complaints, internal audit findings and nonconformances.
• Develops, implements, monitors, and maintains departmental and site level quality metrics (daily, weekly, monthly, quarterly) related to NCRs, DRs, supplier performance and discrepant materials to monitor performance and provide an early warning feedback system to achieve quality objectives.
• Responsible for collecting, analyzing, and reporting discrepancy and nonconformance data in support of Management Reviews.
• Drives continuous improvement within the NCR and DR systems.
• Acts as backup to the CAPA Coordinator
• Other related tasks as assigned by Management.

Minimum Requirements/Qualifications:

• B.A. or B.S. or an equivalent combination of education, experience and/or licensure/certification.
• The required skills, knowledge and abilities that are typically acquired through a minimum of 1 years medical device, pharmaceutical or food industry experience in quality assurance.
• Knowledge of the overall regulatory requirements associated with the development, production, and sale of diagnostic medical products into worldwide markets.
• Strong facilitation, organizational and communication skills.
• Experience and knowledge of ISO 13485: 2016; 21 CFR Part 820 is required.
• Knowledge of the IVD Directive; and Canadian MDR is preferred.
• Must have demonstrated hands on, results oriented, multi-tasking response to the urgent needs of the company and show a strong track record of meeting deadlines.
• Proficient in Microsoft Word and Excel.
• Experience in SAP preferred.

Physical Requirements:

• Normal office and manufacturing environment.
• Position may require frequent communication and walking to other areas in which designated PPE will be required.
• Position will require sitting and standing.
• Employee may occasionally lift and/or move up to 10 pounds.

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.

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