Medical Device Quality Inspector
Talascend is currently seeking a Medical Device Quality Inspector located in Madison, Wisconsin.
Overview
The role involves ensuring that materials, activities, processes, and conditions related to the manufacturing, processing, and packaging of medical devices meet current GMP standards and comply with applicable procedures and standards, including maintaining the quality integrity of the product. The inspector works to ensure compliance with the company's quality system and medical device regulations.
Responsibilities
- Inspect raw materials to meet production requirements.
- Conduct in-process inspection of manufacturing product and processes.
- Review final documentation and shipment packaging for medical devices, subassemblies, and kits.
- Assist in the manufacturing documentation control room.
- Complete documentation of activities performed and prepare material quality status labeling.
- Ensure storage and handling of product and labeling in a controlled and secure manner.
- Support quality through occasional investigations of nonconformance and assist with preventive actions.
- Perform quality reviews for quarantine releases on non-reportable, non-complaint, RMF-3 internal to an RSC.
Qualifications
- High school diploma or equivalent.
- One year of experience in a regulated work environment preferred.
- Knowledge of FDA quality system regulations and ISO13485 pertaining to medical device manufacturing.
- Demonstrated ability to perform the duties of this position through relevant experience, training, or education.
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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.