What are the responsibilities and job description for the Supplier Quality Engineer II (Hybrid - Kennesaw, GA) position at Artivion?
Company Overview:
Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.
Position Overview:
Will establish and maintain procedures for the evaluation and selection of suppliers. Will perform supplier performance reviews and take action for poor performance. Will evaluate and investigate incoming inspection data to correct quality and delivery issues. Will assist in supplier audits to drive process standardization, waste elimination, and continuous improvement. Will ensure that all areas identified as “Principal Responsibilities” are accomplished in an efficient and professional manner.
Responsibilities:
- Investigate supplier quality issues to determine if Supplier Corrective Action Request (SCAR) needed and initiate as needed.
- Facilitate routine changes to supplier status and ensure all required activities are complete.
- Travel to supplier locations to facilitate the resolution of quality problems.
- Act as Supplier Quality liaison for non-conformances.
- Review and communicate supplier requests for engineering changes for routine material or new products.
- Initiate and coordinate supplier communication to implement or revise Supplier Quality Agreements
- Review and communicate supplier requests for engineering changes for new products/supply continuity.
- Ensure Quality compliance throughout affected areas.
- Initiate and coordinate supplier communication to implement or revise Distribution Agreements.
- Assist in establishing and ensuring completion of department and corporate goals.
- Collaborate with cross-functional teams to establish criteria for First Article Inspections of custom materials.
- Assist in Supplier scorecard data gathering and completion.
- Perform supplier audits and facilitate self-surveys for Medical Device.
- Assist Manufacturing Departments in the evaluation and qualification of materials from existing suppliers.
- Facilitate administrative changes to supplier status and ensure all required activities are complete.
- Facilitate complex changes to supplier status and ensure all required activities are complete.
- Act as lead for changes to raw materials, suppliers, distributors.
- Represent Supplier Quality in non-production material projects.
- Provide Supplier Quality support during Notified Body Inspections.
- Compile data for trending and analysis of supplier defects, recurring problems, and supplier corrective actions
Qualifications:
- Bachelor’s Degree with 2-4 years in Engineering, Physical Science or related field.
- Work experience equivalent to education requirements is also acceptable.
- Previous experience in a regulated industry is preferred.
- Previous auditing experience preferred.
- Professional certification(s) such as CMDA, CQA, CQE preferred.
- Excellent oral and written communication skills.
- Good collaborative skills and ability to work with both suppliers and internal staff.
