Position Summary

The Supplier Quality Engineer II is responsible for planning and directing activities concerned with development, application and maintenance of quality standards for processes, materials and products in accordance with quality programs, plans, SOPs and policies of the company’s Quality System. This position is also responsible for ensuring compliance with corporate policies and the company’s active regulatory certifications. This role is focused on supplier quality assurance and supply auditing.

Duties And Responsibilities

• Participate in supplier quality related communication and feedback.
• Support the Material Review Board by recommending or reviewing the disposition of Non-Conforming Material.
• Participate in internal and supplier audits as needed. Ensure that audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule.
• Conduct and assist during external/supplier audits associated with MSD’s active regulatory certifications and requirement compliance.
• Direct the need for Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects. Ensure that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time.
• Generate and analyze metrics needed to measure the effectiveness of the QMS.
• Specific duties may vary depending upon departmental requirements

Experience And Qualifications

• Bachelor’s degree in a technical/scientific/engineering discipline is required.
• Minimum 3 years of experience in biotechnology, medical devices, in vitro diagnostics, pharmaceuticals or related industry is required.
• Working knowledge of and experience with ISO 9001 standard is required.
• Experience with FDA’s Quality System requirements (QSR) and ISO 13485 is preferred.
• ASQ Certified (CQE, CRE, CQA) is beneficial.
• A demonstrated level of consistency in performance and aptitude for managing additional responsibility and accountability are required for next level consideration.

Knowledge, Skills, and Abilities

• Strong quality fundamentals and analytical background.
• Logical problem solving through TQM, team building and quality systems tools and methods.
• Demonstrated ability to organize and move project tasks forward in an orderly and structured fashion.
• Working knowledge of cGMP, ISO and International regulations o Experience with developing, implementing and maintaining Quality System compliance.
• Excellent oral and written communication and interpersonal skills. Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of quality system data.
• Proficiency in MS Office Suite o Capacity to learn additional software applications as the need arises.
• A wide degree of creativity and latitude is expected including the ability to multi-task and work productively in demanding manufacturing and research environments with changing priorities

Physical Demands

This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.

Work Environment

This position is performed in a standard office environment.