Compliance Auditor III
A global healthcare leader is looking for a Compliance Auditor III/ Quality Engineer. This is a great opportunity for someone looking to make a difference and work in a team-oriented environment!
Schedule: 1st shift: M-F 8a-5p (must be flexible for OT)
Job Type: 12 month contract with possibility for permanent conversion
What’s in it for you?:
- Medical and dental insurance
- PTO accrual
The Compliance Auditor/Quality Engineer will be responsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers.
- Supplier Audits: Develop and execute to a supplier audit schedule per current requirements.
- Approve and monitor Supplier CAPA plans and activities to closure.
- Qualify and then monitor supplier performance Per current requirements perform activities that will qualify new suppliers and monitor current supplier base to ensure the status of the suppliers is correct.
- Work with Design and Development, Manufacturing, Purchasing and IQA when qualifying and monitoring supplier performance.
- CAPA Through the supplier audits and internal issues with supplier product, issue SCARs for supplier corrective/preventive action activities.
- Must be able to explain audit results and influence other’s understandings of audit observations in a tactful and professional manner.
- Ability to travel approximately 40% (mostly local)
- Bachelor’s degree in engineering w/ 5 years of related experience OR Master’s degree with 2 years of related experience.
- Must have working knowledge of Quality Systems Regulations (QSR) and International Standards (ISO13485/ ISO14971).
- Knowledge of regulations and standards affecting in vitro diagnostic’s device manufacturing.
- A thorough understanding of the ISO/QSRs
We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!