Associate Quality Engineer – Readycare
Company | Medline |
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Location | Chicago, IL, USA |
Salary | $68640 – $99320 |
Type | Full-Time |
Degrees | Bachelor’s |
Experience Level | Entry Level/New Grad, Junior |
Requirements
- Typically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.
- Experience in processing all relevant details, understanding and prioritizing their importance, and drawing clear and concise conclusions.
- Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
- Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations.
- Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).
- Position may require up to 10% travel.
Responsibilities
- Coordinate stock checks and rework of product as required in response to complaints.
- Identify appropriate actions required to prevent further product complaints. Initiate manufacturing and supplier corrective action reports (CAPA and SCAR) and follow up to ensure corrective actions are implemented. Assist with supplier qualifications.
- Responsible for building appropriate product documentation (e.g. Device Master Records or Drug/Cosmetic Master records) in compliance with applicable regulations. Provide Quality support in Product Development and Risk Management.
- Coordinate product testing with internal and external laboratories as required.
- Assist in the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection procedures to ensure that products are ideal and functional.
- Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.
- Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
Preferred Qualifications
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No preferred qualifications provided.