Medical Device Supplier Engineer CAPA Remediation (Hybrid)

Veterans Sourcing Group, LLC; Maple Grove (MN); Hybride; USD 102 000 - 125 000; Plein temps

Résumé du poste

Veterans Sourcing Group, LLC is seeking a Supplier Engineer in Maple Grove, MN, with a hybrid work model (3 days onsite: Tue–Thu). The role focuses on remediation activities for CAPA 7720 related to CM SFMD products and cross-functional collaboration to ensure quality and regulatory compliance.

Requirements include a Bachelor's in Engineering and 2–5 years manufacturing experience, plus travel up to 15%. Candidates should have strong problem-solving and project management skills and familiarity

Qualifications

• Bachelor's degree in Engineering required.
• 2–5 years of experience in a manufacturing environment.
• Ability to travel up to 15% of the time (domestic possible).
• Problem-solving abilities.
• Manufacturing experience.

Responsabilités

• Review, remediate, and approve CM SFMD supplier's process risk documentation (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 BSC 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, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Build Quality into all aspects of their work by maintaining compliance to all Quality System requirements.

Description du poste

Veterans Sourcing Group, LLC is seeking a Supplier Engineer in Maple Grove, MN, with a hybrid work model (3 days onsite: Tue–Thu). The role focuses on remediation activities for CAPA 7720 related to CM SFMD products and cross-functional collaboration to ensure quality and regulatory compliance.

Requirements include a Bachelor's in Engineering and 2–5 years manufacturing experience, plus travel up to 15%. Candidates should have strong problem-solving and project management skills and familiarity