Heron Therapeutics, Inc. · 1 day ago

Supplier Quality Engineer

Cary, NC

Full-time

Remote

Mid Level

3+ years exp

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Comp. & Benefits

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Responsibilities

Manage end to end performance of all GxP suppliers, including but not limited to: Quality Agreements, Auditing, Audit schedules, Approved Supplier List, Master Supplier Files, Supplier Qualification, Supplier Corrective Action Requests (SCAR), etc.

Oversee the supplier audit program, as lead auditor or coordinator for audits, and work to mitigate major/critical findings.

Managing performance of suppliers via best practices such as Scorecards to drive continuous improvement

Support the supplier selection and qualification process

Work with suppliers to establish control methods suitable to the nature of the product they supply.

Build relationships with suppliers to ensure all levels of manufacturing understand the product requirements.

Responsible for reporting of quality trends and information to management on the performance of supplier.

Work with supplier to establish a structured approach for consistency and adherence to quality procedures and requirements.

Other duties as assigned.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Supplier Quality ManagementISO 13485 Lead AuditorPharmaceuticals ExperienceAPIs KnowledgeMedical Device Industry ExperienceGMP ComplianceGCP ComplianceGLP ComplianceGVP ComplianceContract Manufacturer ExperienceRelationship Building