Junior Supplier Quality Engineer – Med Device Quality & Impact

Acist Medical Systems Inc.; Eden Prairie (MN); On-site; USD 79,000 - 87,000; Full time

Benefits offered by this job

PTO & Company Holidays

401k plan

Health insurance

Job summary

Bracco Medical Technologies is seeking a Supplier Quality Engineer I in Minnesota to provide supplier quality input and support for medical device products. You will collaborate with the Supplier Quality team to deliver results that improve products and ensure compliance with design control procedures and external standards.

You will lead supplier evaluation, qualification, and approval activities, define attribute measurements, own SCARs, and oversee supplier validations and changes.

Qualifications

• BS degree in Engineering or comparable science discipline.
• 0-3 years engineering experience.
• Experience with various inspection equipment (e.g., Optical Inspection Equipment, micrometers, height gages, etc)
• Working knowledge of process validation, test method validation, and R&R study
• Demonstrated knowledge and effective application of quality tools (e.g., Six Sigma, DOE, process analysis/capability, FMEA, root cause analysis, statistical data analysis, CAPA)
• Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
• Experience supporting design assurance/quality engineering deliverables for medical device systems
• Familiarity with manufacturing processes (e.g., Machining, Injection Molding, Investment and Die casting)
• Ability to influence without direct authority
• Ability to establish effective relationships with suppliers
• Moderate level of computer proficiency including MS Word, Excel, ERP systems, and statistical applications software

Responsibilities

• Supplier Quality Participate in and lead supplier evaluation, qualification and approval activities including audits.
• Provide quality support for incoming inspection plans, procedures, and sampling methods to ensure product quality.
• Assist in defining critical attributes and characteristics to be measured for components and products.
• Define component qualification plans and approve first part review results.
• Own and complete Supplier Corrective Action Requests (SCAR), interfacing directly with suppliers.
• Oversee supplier validations, change orders, and any changes to form, fit, or function of the device.
• Provide direction and oversight to manufacturers for quality concerns, product inquiries, validations, safety, etc.
• Identify, Develop, and Implement systems that foster collaboration and communication with suppliers.
• Establish robust measures for supplier quality performance, monitor results regularly, and initiate appropriate actions to continually improve supplier quality performance.
• Participate in and lead continuous improvement projects Manage Supplier scorecards and monitor overall health of Supplier.

Skills

Quality tools

Supplier relationship

Process validation

R&R study

Statistical data analysis

CAPA

Influence without authority

Manufacturing knowledge

MS Word/Excel/ERP

Education

BS in Engineering or related science

ASQ CQE

ASQ CQA

IEC 60601-1 knowledge

Tools

MS Word

MS Excel

ERP systems

Statistical software

Job description

Bracco Medical Technologies is seeking a Supplier Quality Engineer I in Minnesota to provide supplier quality input and support for medical device products. You will collaborate with the Supplier Quality team to deliver results that improve products and ensure compliance with design control procedures and external standards.

You will lead supplier evaluation, qualification, and approval activities, define attribute measurements, own SCARs, and oversee supplier validations and changes.