Technical Support Scientist I
- Manage change control packages for device master records to support product end-of-life documentation and supplier change notifications.
- Project manage activities including product design history file IVDR remediation, UDI activities, and change packages.
- Handle various document types including Manufacturing Procedures, Quality Control Procedures, Certificates of Analysis, Material Specifications, and occasionally Labels/Package Inserts.
- Create thorough and well-drafted change impact assessment documents, ensuring quality documents are properly redlined and in-process revisions are controlled prior to approval.
- Conduct detailed reviews of changes for documents before submission to supervisors/approvers, ensuring all necessary documents for routing change requests are in place.
- Ensure documentation is appropriate, justified, and approved by responsible functional areas within the timeline and in compliance with established procedures.
- Assist with project management by utilizing Smartsheet to track project progress, ensuring timely updates and efficient management of change control activities.
- Collaborate with scientists to problem-solve technical documentation issues and learn the Quality System, document change control, and technical impact assessments.
- Experience with project management.
- Familiarity with Quality Systems and document change control.
- Ability to conduct technical impact assessments.
- Strong problem-solving skills and ability to collaborate with scientists.
- 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)
Recommended Jobs
Locum Tenens Hospitalist Job IL
Though your CompHealth recruiter will be your single point of contact, they are backed by dozens of specialized teams, giving them the ability to focus on the details that matter to you. That means we…
Route Sales Driver
Job Description Pursue a career in the driver’s seat! At Aramark, you can steer your career in the right direction and find limitless opportunities to achieve great things on your way there. …
3rd Shift Receiving Warehouse Team Lead
FRAUD ALERT: Please note that DSV will never request a chat interview or solicit funds from applicants or employees through its interviewing and hiring process. We do not require any form of payment …
Beauty Advisor
Sephora is seeking a Beauty Advisor in Chicago to provide personalized beauty experiences and expert product recommendations. This part-time role requires a passion for beauty, excellent communication…
Human Resources
Description In agreement with our mission at Level 10 in creating authentic, engaging and long-term relationships, we would like to extend any candidate the opportunity to apply and engage in an a…
Motorcycle Sales Associate/Fit Specialist
Illinois Harley-Davidson About Us Illinois Harley-Davidson is a part of the Windy City Motorcycle Company. Windy City Motorcycle Company (WCMC) is a veteran-owned company that operates as more tha…
Service Advisor
Wild Fire Harley-Davidson Villa Park, IL About Us Wild Fire Harley-Davidson/KTM is part of the Windy City Motorcycle Company (WCMC), a veteran-owned and operated company made up of riders fo…
AI Data Scientist, Evaluation & Insights
Ironclad is the leading AI-powered contract lifecycle management platform, processing billions of contracts every year. Every business is powered by contracts, but managing them can slow companies …
Receptionist
LaSalle Network is partnering with our client, a leader in the luxury goods industry , to hire a Receptionist . This is your chance to be the polished, welcoming face of a company whose products …