Supplier Quality Engineer and Supervisor
The Supplier Quality Engneer (SQE) conducts regular audits of manufacturing practices and processes at suppliers' manufacturing facilities to ensure compliance to Acumed and ISO 13485 standards and FDA regulations. The SQE ensures systems for managing suppliers are in place and robust for newly selected suppliers. The SQE oversees the performance and directs the work of the Supplier Quality Technician.
This position has the option to work remotely from a home office OR at the Acumed headquarter office in Hillsboro, Oregon.
- Performs on-site and desk quality system audits of existing and new suppliers, issues corrective actions and follows up to ensure corrections are implemented.
- Continually works with suppliers to improve performance, implement process control and quality plans.
- Develops and implements supplier quality evaluation systems including continuous quality assessment and monitoring.
- Helps manage supplier performance metrics (scorecards) with the Planning group, identifies suppliers who are not meeting required levels, issues Supplier Corrective Action Reports (SCAR) or other performance improvement initiatives and ensures completion as planned.
- Develops and implements plans to improve the performance of business critical suppliers.
- Collaborates with Purchasing/Planning to resolve recurring supply chain issues involving quality and delivery.
- Collaborates with Process and Quality Engineering to engage suppliers in design/process improvements during the concept phase of product development.
- Participates in New Product Development teams for qualifying new supply sources including raw materials, components, sub-assemblies, assemblies, and service suppliers.
- Leads efforts in new supplier qualifications including outsourcing, opportunities, low cost country sourcing, existing supplier replacement.
- Bachelor's degree in Engineering, Quality Assurance, or equivalent technical education required. ASQ certified Quality Engineer (CQE) preferred.
- 5 or more years of experience in manufacturing and/or quality with a working knowledge of inspection techniques and procedures, Six Sigma certified and knowledge of Lean Manufacturing principles desired; medical device manufacturing experience preferred.
- Experience working with International Organization for Standardization (ISO) 13485 standards and conducting supplier audits.
- Working knowledge of applicable Code of Federal Regulations (21 CFR Parts 7, 11, 803, 806,820, etc.) and ISO 13485 systems.
- Detailed understanding of international quality systems (ISO, good manufacturing practices (cGMP), European conformity (CE), etc. Working knowledge of validation installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), process failure modes and effects analysis (FMEA) and failure analysis diagnosis.
- Ability to travel frequently to supplier sites (50%-70%).
- Ability to analyze and present fact based management reporting with recommendations.
- Working knowledge of statistical tools (control charts, statistical process control (SPC), probability, and trending).
- Ability to analyze data for accuracy and correctly interpret and report on results.
- Excellent English communication skills, both verbal and written
- Ability to communicate effectively, make presentations and write concise reports for all levels of employees.
- Proficient in MS Word and Excel and PowerPoint, MS Outlook; experience with SAP preferred.
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