Quality Engineer - Biotech

Mantell Associates is partnered with a global leader in the development, manufacture, and commercialization of innovative assays and instruments. They are seeking a Quality Engineer to join their growing team.

Quality Engineer - Responsibilities:

• Participate on New Product Development (NPD) project teams
• Promote compliance to the Quality Management System processes and procedures and provide guidance to project teams on the elements of design controls as defined by the QMS
• Review deliverables of the design and development process for conformity to internal and external requirements
• Maintain the design history files and risk management files
• Oversee supplier management activities for NPD projects
• Serve as Quality representative on validation activities (e.g. equipment, process, assay, spreadsheet, software, facilities and utilities)
• Support the projects under the Master Validation Plan
• Develop strategies and revise validation procedures/protocols to ensure that products are manufactured in accordance with appropriate current industry standards
• Compile and analyze validation data, prepare documentation, and make recommendations for changes and/or improvements
• Define, document, and continuously improve verification plans and protocols including conducting peer reviews and maintaining traceability to requirements
• Analyze data by completing hypothesis, normal distribution, and process capability analysis tests
• 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
• Assist during external audits associated with active regulatory certifications as well as customer audits
• 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 requirement

Quality Engineer - Requirements:

• Bachelor's degree or Master's degree in a technical/scientific/engineering discipline is required
• Minimum of 4 years of experience in medical devices, in vitro diagnostics, pharmaceuticals or related industry is required
• Experience planning and implementing quality plans and programs preferred
• Working knowledge of and experience with FDA's Quality System requirements (QSR), ISO 9001 and ISO 13485 standards is preferred
• Relevant ASQ Certification (e.g. CQE, CRE, CQA) is beneficial
• Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred, including Measurement System Analysis, SPC, DOEs, Reliability, etc.

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +1 (786) 485 1298.