cGxPServe

SQ Engineer

8 days ago

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Roles & Responsibilities

Ensures that the division's Approved Supplier List is maintained and accurate.
Assesses potential new suppliers and service providers for quality and quality system capabilities through the execution of on-site or desk top audits, and review of other objective evidence.
Communicates approval requirements to supplier and monitors feedback per project timelines.
Performs on-site quality assessments of new suppliers, as required, and ensures appropriate corrective action response to findings.
Documents any changes to supplier status.
Issues supplier corrective action requests for nonconforming supplied material and works with the supplier on the investigation and resolution of root cause issues.
Notifies suppliers of customer complaints related to failures resulting from supplied material and requires investigation and corrective action.
Monitors supplier performance and reports supplier quality trend data.
Participates with Incoming Quality Control on the development of incoming inspection activities or the reduction of these activities.
Responsible for approving First Article Inspections, as initiated by suppliers.
Assists with the evaluation and approval of supplier requested.
4 6 years of relevant experience. Experience working in medical device industry is a must.
Well-developed written, oral and interpersonal skills is a must.
Candidate having Supplier Audit certification is an advantage.