Supplier Quality Engineer I

Position Summary:
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.

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%.