Supplier Quality Engineer I - Bracco Medical Technologies

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

Why Join Bracco Medical Technologies?

We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day! The Supplier Quality Engineer I will provide supplier quality input and support for products manufactured by Bracco/ ACIST Medical Systems. This role collaborates with the Supplier Quality team to deliver results that improve products and identifies areas of improvement. This role also provides direction in product risk management throughout the entire lifecycle and assure compliance to ACIST design control procedures, applicable regulations, and external standards. The role works upstream and downstream ensuring the total product lifecycle is maintained and that our products continue to perform as designed.

Primary Duties & 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.

Receiving Inspection and Manufacturing Quality Assurance:

• Resolve NCMRs related to incoming material inspections.
• Assist in defining critical attributes and characteristics to be measured for components and products.

Material Review Board:

• Manage and the material review board for Operations including data generation and analysis, meeting execution, any follow up activities, meeting minutes, and filing of all MRB records.
• Generate Supplier Scorecards with the assistance from Global Supply Chain and Quality Engineering.

Does this position have supervisory authority? Yes No

Qualifications (Knowledge, Skills & Abilities):

• Minimum 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

Preferred:

• 1+ yrs experience in a Quality Engineering role, preferably in med device industry
• ASQ CQE (Certified Quality Engineer) or 6 Sigma discipline
• ASQ CQA (Certified Quality Auditor) or related auditing certification
• Knowledge and experience with IEC standards such as 60601-1, 60601-1-2, and other related standards for the product type
• Ability to coordinate multiple projects simultaneously

Other:

• Mental demands – work is detail oriented, often with multiple priorities.
• The environment is deadline sensitive and may be exposed to high‑pressure situations.

Travel requirements are minimal. Travel to facilities would be about 3-5 days duration each trip with total travel expected to be approximately 15%.

Compensation & Total Rewards:

• Estimated starting salary: 79,000.00 - $87,000.00 *Estimated starting salary is intended to reflect the salary Bracco Medical Technologies reasonably expects to pay for the position. The provided range is based on salary and market data and may vary based on an employee's eligibility for geographic differential pay in high-cost-of-labor markets.
• Total Rewards: Paid Time Off, Company Holidays & Paid Family Leave – We provide PTO and Company Holidays to help you recharge, relax and do what’s important to you, when it’s important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
• Achieve – Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
• Live well – We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
• Evolve – Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you’ll find many opportunities to grow, personally and professionally.
• Choose –You won’t find “stuffy” here whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.

Bracco Medical Technologies is an Aff… Bracco Medical Technologies desires priority referrals of protected veterans for all openings.

Improve people’s lives by shaping the future of prevention and precision imaging. This is our purpose. Our work impacts millions of people all over the world. Not least the more than 4,000 Bracco colleagues who work to improve lives every single day. That is quite a responsibility and something we proudly embrace.

We are the Bracco Group!