Supplier Quality Engineer I — Hybrid (Med Device)

Bracco Medical Technologies; Eden Prairie (MN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Paid Time Off, Company Holidays & Paid

Family Leave

Annual incentive plan

401k contributions

Medical, dental, vision, lifeinsurance

HSA contributions

Employee assistance program

Tuition reimbursement

Hybrid or in-office flexibility

Job summary

Bracco Medical Technologies is seeking a Supplier Quality Engineer I to support supplier quality input for Bracco/ACIST Medical Systems products and manage lifecycle quality activities. The role collaborates with the Supplier Quality team to drive product quality improvements and ensure compliance with design controls, regulations and external standards.

The position involves leading supplier evaluations, qualifying components, managing SCARs, MRBs and supplier scorecards, with travel up to 15%

Qualifications

• BS degree in Engineering or comparable science discipline.
• 0-3 years engineering experience.
• Experience with inspection equipment (e.g., optical devices, micrometers, height gages).
• Knowledge of process validation, test method validation, and R&R study.
• Knowledge of FDA QSR/ISO 13485/Medical Device Directive.
• Travel up to 15%.

Responsibilities

• Participate in and lead supplier evaluation, qualification and audits.
• Provide quality support for incoming inspection plans, procedures, and sampling methods.
• Assist in defining critical attributes and characteristics to be measured.
• Define component qualification plans and approve first part review results.
• Own and complete SCARs, interfacing with suppliers.
• Oversee supplier validations and change orders.
• Provide direction to manufacturers for quality concerns and validations.
• Establish robust measures for supplier quality performance and improvements.
• Participate in and lead continuous improvement projects.
• Manage supplier scorecards and monitor supplier health.

Skills

Attention to detail

Strong communication

Ability to influence without authority

Cross-functional collaboration

Education

Bachelor's degree in Engineering or comparable science

Tools

Optical Inspection Equipment

Micrometers

Height gages

MS Word

Excel

ERP systems

Statistical software

Job description

Bracco Medical Technologies is seeking a Supplier Quality Engineer I to support supplier quality input for Bracco/ACIST Medical Systems products and manage lifecycle quality activities. The role collaborates with the Supplier Quality team to drive product quality improvements and ensure compliance with design controls, regulations and external standards.

The position involves leading supplier evaluations, qualifying components, managing SCARs, MRBs and supplier scorecards, with travel up to 15%