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Supplier Quality Engineer

Overview
The Supplier Quality Engineer (SQE) develops, implements and manages the supplier quality program. Establishes a communication and effective interaction focused on solving quality issues; identifies improvement opportunities and, selects components/materials and suppliers to certify and conduct the entire process of certification.
Conducts regular audits of manufacturing practices, quality system and processes at suppliers' manufacturing facilities to ensure compliance to Bard and ISO 13485 standards and FDA regulations. Individuals in this capacity are expected to perform in a unified, coordinated team effort under the direction of the Manager of Quality Assurance to establish partnerships with key suppliers to improve the quality and on time delivery of supplied materials while achieving cost containment. This position interacts with procurement, manufacturing and engineering, as well as supplier representatives to improve processes that impact supplied materials.
Summary of Position with General Responsibilities
Responsible for the Approved Supplier List and Supplier audit schedule.
Performs on-site and desk quality system audits of existing and new suppliers, issues corrective actions and follows up to ensure corrections are implemented.
Manages and maintains the audit files and the supplier corrective action,
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 Materials 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 the problem solving issues with raw materials/components with the plant manufacturing areas, Process and Quality Engineering. Liaison between facility and suppliers.
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 and supplier certification.
Material Review Board member ? Disposition and resolve non-conformance issues of supplied materials.
Coordinate meetings for Supplier Certification
Any other task assigned by Supervisor
Basic Qualifications
To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Strong knowledge of statistics on quality engineering techniques.
Excellent communication skills, both verbal and written
Excellent interpersonal skills.
Education and/or Experience
Bachelor's degree in Engineering, Quality Assurance, or equivalent technical education required.
Certified Auditor (CQA, Exemplar Global, etc) or ASQ certified Quality Engineer (CQE)
2 - 4 years in medical device manufacturing environment.
Physical Demands
Knowledge of manufacturing processes, procedures, and production equipment.
Ability to write technical documents.
Ability to work independently and as part of a team.
Demonstrated proficiency working with computers and the Micro Soft operating systems.
A working knowledge of quality improvement tools and techniques.
Experience with FMEA, DOE, SPC, and related statistical tools.
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 analyze data for accuracy and correctly interpret and report on results.
Ability to communicate effectively, make presentations and write concise reports for all levels of employees.
Requires domestic and international travel.
Working knowledge of inspection techniques and procedures, Six Sigma certified and knowledge of Lean Manufacturing principles desired; medical device manufacturing experience.
Work Environment
While performing the duties of this job, the employee is frequently required to stand; walk; use hands or arms (to finger, handle or feel objects, tools, or controls). The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear.
The noise level in the work environment is normally quiet to moderate.

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