Supplier Engineer

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

Location: Maple Grove, MN 55311 – (Hybrid 3 days onsite - Tuesday, Wednesday, Thursday)

Shift: Business 1st Shift (8:00 AM – 4:30 PM)

Looking For

• Problem solving, with the ability to showcase examples
• Manufacturing experience

About the Role

This Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for Client's contract manufactured (CM) sourced finished medical device (SFMD) product. This individual works independently, serves as a leader for SE remediation activities, and interacts cross-functionally with Client team members and CM SFMD suppliers to execute deliverables according to business needs.

Responsibilities

• 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

Quality Systems Duties and Responsibilities

• Build Quality into all aspects of their work by maintaining compliance to all Quality System requirements.

Required Qualifications

• Bachelor's degree in Engineering is 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

Preferred Qualifications

• Experience working with suppliers or in supply chain management
• Experience working in the Medical Device Field
• Experience with Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualification (PQ), and Test Method Validation (TMV)
• Excellent communication and project management skillsStrong bias for action and results oriented
• Self-driven and self-motivated to learn and apply knowledge to produce results
• Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies

Conversion Potential: Possible temp to hire for the right individual, if budget is approved. Approximately midpoint salary is $113,500. Suppliers must mark salary expectations on submittal form, within reason of the above.