Customer Quality Coordinator
Inginaire is looking for a Customer Quality Coordinator for our client in Bloomington, MN. Our client is a fast-growing dynamic leader within the Twin Cities medical device industry. They offer technical services to assist medical device OEMs throughout the nation with clean room assembly and packaging operations. As an employee you will enjoy a culture founded on teamwork, respectful communication, creative problem solving, dependable follow through and excellent customer service! The ideal candidate is energetic, responsive and well-organized. They will have the ability to successfully multi-task and adapt to change in our fast-paced, dynamic environment. This position is responsible for providing quality support to a designated internal team by performing documentation review and audit support.
- Provide team guidance related to meeting the 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 internal system and the customer requirements.
- Provide support for customer audits, questionnaires, complaints, NCR?s, CAPAs, and quality system information requests.
- Skills and knowledge equivalent to those obtained in a technical program or certificate related to the Quality Field with a minimum of 3 years work related experience.
- 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.