Supplier Quality Engineer

Job Description

Job Description

Job Title: Supplier Manufacturing Engineer

Duration: 12+ Months (Possible temp to hire)

Location: Maple Grove, MN 55311

Hybrid Role

 

Responsibilities:

• Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for 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 team members and CM SFMD suppliers to execute deliverables according to business needs.
• 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 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 functional resources to complete all activities needed to approve supplier’s process risk documentation and process/inspection validations to the newly defined criteria.
• 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.

Education/Experience:

• Bachelor’s degree in engineering is required!
• 2-5 years of experience in a manufacturing environment.
• Problem solving, being able to showcase examples
• Manufacturing experience
• Validation experience
• Change management experience
• Ability to travel up to 15% of the time. (Domestic possible.)

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 skills.
• Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies.