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Job ID :
54234BR
Location :
US - Virginia - Middletown
:
Job Description
As the world’s leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial and applied markets, generating more than $18B in annual revenue. No other company can match our range of customer touch points – technologically, geographically or commercially. We help our customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives.


The Specialty Diagnostics Group (SDG) serves customers in healthcare, clinical, pharmaceutical, industrial, and food safety laboratories. SDG consists of a dedicated team of 6,900 talents determined to improve diagnostic methods in order to improve patient care and accuracy of diagnoses. The group offers a wide range of diagnostic test kits, reagents, culture media, instruments and associated products. Together, we are moving medicine forward by bringing advanced diagnostic tools that improve the quality, reliability and speed of diagnostics.


Position Summary:
  • Serve as a primary interface with customer quality assurance teams to respond to customer requests for documentation, data, investigations, risk assessments and testing.
  • Provide investigation and root cause analysis support to Technical Services for customer complaints, CAPAs and SCARs.
  • Work with laboratory, engineering, facilities, regulatory and PD/PS to collect data and documentation needed to respond to customer requests.
  • Serve as project manager for small-to-mid scale customer-facing projects such as corrective actions, process improvements and process monitoring.
  • Lead cross functional teams for small-to-mid scale customer-facing projects. Assemble team, conduct meetings, create and maintain milestones and timelines, provide reports and updates to management.
  • Participate as team member on large scale customer-facing projects providing needed support and expertise to project manager.
  • Manage customer specifications and customer requested changes.
  • Conduct risk assessments in support of customer quality issues and changes.
  • Issue Customer Change Notifications to customers as necessary based on Supplier Change Notifications or internal engineering and manufacturing projects.
  • Assist in training and maintaining compliance to regulations and procedures.
  • Participate in PPI and Lean projects and activities to improve productivity.
  • Other related tasks as assigned by Management.

Minimum Requirements/Qualifications:
  • Bachelor’s degree in Science or Engineering or related discipline.
  • ASQ certified engineer and ASQ certified auditor preferred.
  • Minimum of 5 years quality experience with a medical device company.
  • Knowledge of global regulatory and quality requirements associated with medical devices.
  • Working knowledge of ISO 13485:2003, 21 CFR Part 820, IVDR and Canadian MDR.
  • Experience in formal problem solving in a team environment.
  • Detail oriented and has the ability to lead multiple projects and activities assigned.
  • Excellent organizational skills, planning, communication and follow up skills.
  • Proficient in Microsoft Word and Excel. SAP experience preferred.
  • Travel up to 10% of time.


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

This position has not been approved for relocation benefits.


At Thermo Fisher Scientific, each one of our 55,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.



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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