POSITION SUMMARY:

The 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.

DUTIES AND RESPONSIBILITIES: 

New Product Development 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.

 

Validation Support 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.

 

Quality Assurance 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 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 CAPAs 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 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.

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 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 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 will spend time in a Low Particulate Room environment.