Supplier Quality Engineer I - Med Device, Growth & Impact

Bracco Medical Technologies; Eden Prairie (MN); On-site; USD 79,000 - 87,000; Full time

Benefits offered by this job

Paid Time Off

Company Holidays

Paid Family Leave

401k contributions

Medical, dental, vision insurance

Tuition reimbursement

Job summary

Bracco Medical Technologies is seeking a Supplier Quality Engineer I in Eden Prairie, MN to support supplier quality activities for medical devices. The role partners with the Supplier Quality team to improve product quality and maintain lifecycle integrity.

The candidate will manage supplier evaluations, SCARs, and supplier scorecards, while ensuring compliance with FDA QSR, ISO 13485, and related standards.

Qualifications

• Bachelor's degree in Engineering or a comparable science discipline is required.
• 0-3 years of engineering experience is typical for this role.
• Experience with inspection equipment helps ensure product quality.
• Working knowledge of process validation, test method validation, and R&R studies.
• Familiarity with FDA QSR, ISO 13485, and Medical Device Directive is preferred.
• Experience supporting design assurance/quality engineering deliverables for medical devices.

Responsibilities

• Lead supplier evaluation, qualification and approval activities including audits.
• Provide quality support for incoming inspection plans and sampling methods.
• Define attributes to be measured for components and products.
• Own supplier corrective action requests (SCAR) and interface with suppliers.
• Oversee supplier validations, change orders, and form/fit/function changes.
• Provide direction to manufacturers for quality concerns and validations.
• Establish measures for supplier quality performance and drive improvements.
• Participate in continuous improvement projects and manage supplier scorecards.
• Resolve NCMRs related to incoming materials and assist in attribute definitions.

Skills

Quality tools

Statistical analysis

DOE methods

CAPA

Root cause analysis

ERP systems

MS Excel

Education

BS degree in Engineering or comparable science

ASQ CQE

ASQ CQA

Tools

Optical inspection equipment

Micrometers

Height gauges

Job description

Bracco Medical Technologies is seeking a Supplier Quality Engineer I in Eden Prairie, MN to support supplier quality activities for medical devices. The role partners with the Supplier Quality team to improve product quality and maintain lifecycle integrity.

The candidate will manage supplier evaluations, SCARs, and supplier scorecards, while ensuring compliance with FDA QSR, ISO 13485, and related standards.