Entry-Level Supplier Quality Engineer — Med Devices

Bracco; Eden Prairie (MN); Hybrid; USD 79,000 - 87,000; Full time

Benefits offered by this job

Paid Time Off

Company Holidays

Paid Family Leave

401k plan

Annual incentive plan

Medical insurance

Dental insurance

Vision insurance

Life insurance

Employer HSA contributions

Employee assistance program

Short-term disability

Job summary

Bracco Medical Technologies is seeking a Supplier Quality Engineer I to join the quality team supporting Bracco/ ACIST Medical Systems products. You will work with suppliers on qualification, audits, SCARs, and change controls while ensuring compliance with design controls and regulatory standards.

Ideal candidates have a BS in engineering, 0–3 years of relevant quality engineering experience, and familiarity with medical device manufacturing processes.

Qualifications

• BS degree in engineering or related science field.
• 0-3 years engineering experience in quality or med device context.
• Experience with inspection equipment and validation activities.
• Strong knowledge of quality tools and problem solving (Six Sigma, DOE, FMEA, CAPA).
• Familiarity with FDA QSR, ISO 13485 and Medical Device Directive.

Responsibilities

• Participate in supplier evaluation, qualification and audits.
• Support incoming inspection plans and sampling methods.
• Define critical attributes and measurement plans.
• Own supplier corrective actions and SCAR processes.
• Oversee supplier validations and change orders.
• Provide direction on supplier quality concerns and product inquiries.
• Develop and monitor supplier quality performance metrics.
• Lead continuous improvement projects with suppliers.
• Prepare supplier scorecards and MRB related activities.
• Address NCMRs related to incoming materials.

Skills

Influence without authority

Quality tools

Statistical analysis

Root cause analysis

Process validation

Experience with medical devices

MS Word/Excel/ERP

Education

BS in Engineering or comparable science

Tools

Optical inspection equipment

Micrometers

Height gauges

Process validation tools

Job description

Bracco Medical Technologies is seeking a Supplier Quality Engineer I to join the quality team supporting Bracco/ ACIST Medical Systems products. You will work with suppliers on qualification, audits, SCARs, and change controls while ensuring compliance with design controls and regulatory standards.

Ideal candidates have a BS in engineering, 0–3 years of relevant quality engineering experience, and familiarity with medical device manufacturing processes.