Technical Support Scientist IV

Title: Technical Support Scientist IV

Location: Irving, TX/ Lake Forest, IL (100% Onsite)

Duration: 4+ Months

Description

• Responsible for the transition from IVDD to IVDR compliance for ~400 products both Abbott and TPM legally manufactured products. Currently, some of these products have been launched, but we are continuing to make the products IVDR-compliant and finalize pre-launch deliverables and answer country-specific questions about labeling/technical document updates.
• Review product gap assessments created for products in 2020/2021 and update technical documentation as appropriate to ensure product documentation are IVDR-compliant.
• Provide technical input and review to update the Technical Files
• Update labelling (information for use, kit and vial labels)
• Update Performance Evaluation documents
• Create/update design plan deliverables
• Answer country regulatory questions about the updated technical files
• Work in alignment with other ADD sites (Sligo, Wiesbaden, Longford, or Dallas), other Abbott Divisions, and the TPMs.
• The candidate will be a part of a cross-functional team that will predominantly consist of other technical team members, technical/medical writers, project management, quality, global and country regulatory team members.
• Work in alignment with other Abbott initiatives such as the EU regulation on chemicals, Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH), Alinty launches etc.

Experience:

• 2 years min, technical background and experience in the diagnostics field, specifically immunoassays (IA) and clinical chemistry (CC). Lab experience is ideal so that the candidate knows how IA/CC instruments, reagents, calibrators, and controls are utilized and tested. Abbott experience is a plus.
• Technical writing and strong communication skills (oral and written) including giving oral presentations.
• Flexible, collaborative, outside the box but within the rules thinking
• This is not a laboratory position but will require the candidate to have previous clinical/diagnostic lab experience and understanding of how testing in that environment is conducted.

Skills:

• Understanding of Design Verification/Validation Testing (CLSI and European guidelines)
• Project Management
• Risk Management
• Design Planning
• Change Control
• Labelling changes

Education:

• Bachelor's degree in scientific or technical field

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.