Senior Supplier Engineer | Medical Devices (Hybrid, MN)

Pharmavise Corporation

Maple Grove (MN)

Ibrido

USD 85.000 - 105.000

Tempo pieno

2 giorni fa

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Descrizione del lavoro

Pharmavise Corporation in Maple Grove, MN, is seeking a Supplier Engineer III for a hybrid role focused on remediation activities tied to CAPA 7720 for CM SFMD products. The role leads remediation efforts and collaborates across client teams and suppliers to deliver compliant, high-quality results.

The position requires a Bachelor’s degree in engineering, 2–5 years of manufacturing experience, and travel up to 15%.

Competenze

Bachelor’s degree in engineering is required.
2–5 years of experience in a manufacturing environment.
Ability to travel up to 15%.
Problem solving abilities.
Change management experience.

Mansioni

Review, remediate, and approve CM SFMD supplier’s PFMEA to newly defined criteria.
Review, remediate, and approve CM SFMD supplier’s process and inspection validations to client’s statistical requirements.
Perform change management activities to remediate gaps found in CM SFMD Supplier’s process risk documentation and process/inspection validations.
Collaborate with CM SFMD suppliers and client’s functional resources to complete all activities needed to approve supplier’s process risk documentation and process/inspection validations to the newly defined criteria.
In all actions, it demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.