Engineer III, Quality

The Quality Engineer III serves as a subject matter expert 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 mentoring and/or supervising more junior QA team members and ensuring compliance with corporate policies and the company’s active regulatory certifications.

• Participate on New Product Development (NPD) project teams.
• Ensure compliance to the Quality Management System (QMS) 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.
• Oversee resources that 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 to ensure that products are manufactured in accordance with appropriate current industry standards and provide guidance to resources who revise validation procedures/protocols
• Compile and analyze validation data, prepare documentation, and make recommendations for changes and/or improvements, as needed for validation of complex projects and oversee resources performing these activities for lower complexity projects.
• 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.

• Lead supplier quality related investigations.
• Support the Material Review Board by recommending or reviewing the disposition of Non-Conforming Material.
• Lead 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 MSD’s 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 requirements; engineers at this level may have either broad responsibilities in the areas described above or more focused responsibilities requiring greater subject matter expertise.

• Bachelor’s degree in a technical/scientific/engineering discipline is required.
• Master’s degree is preferred
• Minimum of 7 years of experience in medical devices, in vitro diagnostics, pharmaceuticals or related industry is required, in positions of increasing responsibility.
• Experience with developing, implementing and maintaining Quality System compliance strongly preferred.
• Experience planning and implementing quality plans and programs preferred.
• Experience in mentoring/training preferred.
• Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred, including but not limited to Measurement System Analysis, SPC, DOEs, and Reliability.
• Relevant ASQ Certification (e.g. CQE, CRE, CQA) is beneficial.