Medical Device Quality Inspector
Talascend is currently seeking a Medical Device Quality Inspector with our client in Madison, Wisconsin.
OVERVIEW
Responsible for assuring that materials, activities, processes, and specified conditions related to the daily device manufacturing, processing and packaging meet current GMP standards and comply with applicable procedures and standards.
RESPONSIBILITIES
- Inspecting raw materials to meet production requirements
- Conducts in-process inspection of manufacturing product and processes
- Reviews final documentation and shipment packaging for medical devices, subassemblies, and kits
- Assists in the Madison Manufacturing documentation control room
- Completes documentation of activities performed, prepares and attaches material quality status labeling
- Ensures storage and handling of product and labeling in a controlled and secure manner
- Supports Quality through occasional conduct of investigations of nonconformance
- Assists with preventive actions associated with the QA unit
- Performs quality reviews for quarantine releases on non-reportable, non-complaint, RMF-3 internal to an RSC
- High School diploma or equivalent
- 1 year experience in a regulated work environment preferred
- Knowledge of FDA Quality System Regulations and ISO13485 pertaining to medical device manufacturing
- High Level of motivation; ability to work independently
- Detailed oriented
- Ability to work with computer-based systems daily
- Collaborator with strong levels of engagement with individuals and as a team member
- Good interpersonal skills; ability to communicate well, both verbally and written
We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.
Background Check and Drug Screen may be required.
Talascend is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.