Job ID :
US - Kansas - Lenexa
- Audits (reviews) manufacturing documentation (hardcopy and online) for accuracy and completion.
- Attends meetings to give feedback to Product Value Stream teams
- Expedite documentation issues to ensure timely disposition of products.
- Appropriately escalates any product issues to Quality and Production management teams.
- Leads day-to-day activities to ensure swift and accurate completion of product disposition activities.
- Collaborates with the manufacturing, planning, and distribution departments to troubleshoot and solve problems.
- Maintains standards in accordance with cGMP's/SOP's and ISO regulations.
- Supports tracking departmental metrics and meeting departmental goals.
- Supports training of new employees on process flow and documentation.
- Manage a continuous improvement program within the Quality Assurance department.
- Follows and supports all company policies.
- Performs other duties as assigned.
- Possess high school diploma or GED minimum, Associates degree preferred.
- Possess proficient computer skills, preferably with experience in Word, Excel and SAP programs.
- Course work in the sciences/engineering is a plus.
- Document review experience is preferred.
- Familiarity with FDA regulations for medical devices is a plus.
- Possess the ability to manage many tasks in an organized fashion.
- Listen to, and follow, written and verbal instructions.
- Possess excellent oral and written communication, and problem-solving skills.
- Works well independently and within a team environment.