Supplier Development Quality Engineer

Job Summary:

• Looking for at least 2 or more years of experience preferably in med device but aerospace or another highly regulated industry could work.
• Preferred fields for a education/degree are biomedical, mechanical, industrial, or quality engineering.
• Work will have a technical focus with an emphasis on processes, manufacturing, and quality.
• Must have good communication skills both verbally and written.
• Will be working with external suppliers and internal team members to develop and/or expand the supplier quality program.
• 25% travel with mostly local travel but could be some air travel to MN as well.
• Interview process will be an initial phone or virtual screen by the HM and then a panel virtual interview with other members of the team.
• Potential to convert to FTE or extend is a possibility but not a guarantee (depends on candidate performance/budget etc.)

Description:

• Supplier Development Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection.
• Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet regulatory requirements.

Key Bullet Points:

• Supplier Engineer as part of overall Supplier Excellence Team Part of the Supply Chain organization Focused on collaboration with internal/external (supplier) teams on existing products Review of drawings & specifications to ensure 100% alignment between supplier for measurement techniques, specifications, etc.
• Review of supplier processes (manufacturing & quality assurance) for compliance with current specifications/validated processes & potential improvements Verification and/or validation of process changes and/or improvements Experience level is 4 years focused on Supplier Engineering and/or Supplier Quality Engineering Heavy focus on process quality & assurance Travel to suppliers is expected (25%) and funded by.

Call notes from Hiring Manager:

• To work with suppliers on quality, process alignment.
• Travel might be involved (20-25%, will be funded by).
• Collaborate with suppliers and with internal teams for quality management with different internal teams.
• Supplier quality development, supplier Process engineering, quality engineer with supplier quality, titles would work.
• Collaborating cross functional teams is important.
• Med device is ideal, aerospace/defence is second preference industry would be preferred in past.
• Electro- mechanical, mostly mechanical parts will be dealing with.
• Biomedical Engineer would be good, mechanical engineer, electrical engineering would be ok.
• Supply chain is also important.
• To improve quality management, quality inspection, quality control plans.
• 2-4 years if med device background, 5-7 without med device (aerospace/defence or any regulated industry)
• There is not overqualification.

Description:

• Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development.

Required Skills:

• Electro-Mechanical & Mechanical Components
• Regulatory Requirements Compliance
• Process Improvement & Optimization
• Manufacturing & Process Validation
• Medical Device Industry (Preferred)
• Supplier Development Engineer
• Supplier Quality Engineering
• Supplier Process Engineering
• Supplier Selection and Evaluation
• Supplier Performance Management
• Supplier Quality Development

Preferred Skills:

• Biomedical, Mechanical, Industrial, or Quality Engineering Background
• Experience in Medical Device, Aerospace, or Other Regulated Industries
• Knowledge of FDA, ISO 13485, and Other Regulatory Standards
• Experience with Manufacturing Process Improvement
• Hands-on Experience in Supplier Quality Audits
• Root Cause Analysis & Corrective Action Implementation
• Risk Management & Failure Mode Analysis (FMEA)
• Understanding of Electro-Mechanical Components
• Supplier Quality Program Development

SAP or Other ERP Systems