Opportunity Description
Purpose Statement: The Quality Engineer leads determination of non-conformance and customer complaints through containment, root cause, corrective action, and audits.
They ensure product compliance to customer specifications and industry standards.
Key Job Accountabilities:
- Compliance: Ensure products comply with customer specifications, industry standards, regulatory requirements and Plexus standards.
Ensure ABIs comply with specifications and standards.
Approve all changes and deviations from established guidance, including ECOs.
Lead creation and maintenance of the Master Validation Plans, when required; ensure compliance.
Support creation and execution of IQ OQ PQ protocols to ensure compliance with the Master Validation Plan.
Serve as the Plexus lead to support external customer audits and internal audit activities.
Support recertification and surveillance QMS audits.
Lead product-related CAPA discussion and closure.
- Quality Assur...