Customer Quality Coordinator
Inginaire is seeking a Customer Quality Coordinator for our client located in Bloomington. Our client is a Cretex Medical Company that is a fast-growing dynamic leader within the Twin Cities medical device industry. The individual is responsible for providing quality support to a designated internal team by performing documentation review and audit support. This is a direct hire opportunity.Duties
- Provide team guidance related to meeting our clients Quality Management System.
- Monitor sterilization and testing requirements/events for customers (dose audits, bioburden testing, etc.)
- Perform customer-related document change request (DCR) reviews for meeting the our client's system and the customer requirements.
- Provide support for customer audits, questionnaires, complaints, NCR's, CAPA's, and quality system information requests.
- Ability to successfully multi-task and adapt to change in our fast-paced, dynamic environment.
- Skills and knowledge equivalent to those obtained in a technical program or certificate related
- Experience with ISO Quality Systems, ISO 13485 training and experience preferred
- Internal Audit Experience, CQA preferred
- CAPA Management and problem-solving skills using QA tools
- Familiar with sterilization processes and direct customer interaction
- Knowledge of blue print reading and a basic understanding of dimensions and tolerances