Job Description

The Quality & Process Enginee r is a valued member of the Operations and Quality team. Reporting to the Director of Quality, this role is responsible for design quality engineering support of design transfer and customization/configuration projects, root cause analysis, process improvements, complaint investigations, CAPA projects, auditing, NCR and other QMS related activities including KPI reporting, evaluating and driving actions to reduce risk associated with internal and supplier processes, developing, modifying and maintaining quality plans and continuous improvement activities.

The Quality Engineer ensures equipment, process and software validations are executed appropriately and coordinates equipment calibration activities. This role requires strong attention to detail, organizational skills, the ability to communicate, and a willingness to adapt to changing business needs.

Essential Job Functions:

Design Quality Engineering Support

• Default department representative for New Product Development design review activities.
• Supports all design transfer projects, leading when assigned, to ensure customization and configuration of contract manufacture or other customer specified products and processes are properly documented, implemented and transferred to manufacturing operations
• Root Cause & Process Monitoring
• Facilitate and promote use of appropriate problem-solving techniques for effective root cause analysis and successful corrective action.
• Reviews escalated root cause evaluations utilizing established RCA tools.
• Utilizes statistical techniques to verify effectiveness of corrective actions as well as proactively identify opportunities for preventive actions.
• Analyzes internal and suppler process data to ensure quality standards are met.
• Leads formal CAPA investigations as assigned.
• Responsible for ensuring product complaints are properly investigated, documented and closed.
• Participate in quality reporting and management review process

Risk & Change Management

• Issues and maintains pFMEAs.
• Documents and reviews risk assessments, as identified, for investigations from various sources such as CAPAs, NCRs and complaints.
• Reviews changes, both planned and unplanned, to support identification and mitigation of risks and to ensure change plans are adequate and effectively executed based on impact.
• Support Quality and operations personnel with determining nonconforming material or process impact on finished product functionality.

Inspection Methods and Quality Plans

• Develop, modify and verify inspection methods for raw materials, in -process inspections and finished good acceptance activities utilizing appropriate statistical techniques and measurement system analysis tools.
• Create and maintain Quality Plans for internal processes and contract manufacturers based on provided product design, quality and external standard requirements.
• Supports evaluation and monitoring of suppliers to ensure quality requirements and plans are met as applicable.

Validations

• Develops assigned validation protocols, coordinates and executes protocols and generates reports for the applicable Quality Control equipment and processes as well as companywide software validations utilizing IQ,OQ and PQ methods.
• Reviews validation protocols, deviations and reports generated by internal and supplier engineering or manufacturing personnel to ensure requirements are met based on process, risk, validation procedures and external regulatory standards.
• Develops and executes process verification activities as assigned.
• Calibration
• Reviews the appropriate investigation and implementation of corrective actions for calibration failures.
• Supports the identification of calibration cycles for new and existing equipment based on manufactures recommendations, use and history.
• Continuous Improvement
• Determine when process capability studies should be performed on existing processes. Review and analyze results. Recommend changes to processes based upon findings and perform follow up to verify effectiveness.
• Leads and actively participates in improvement (6 Sigma, Lean, and Compliance Improvement) projects as assigned.
• Conducts Internal and Supplier Audits as assigned
• Other duties as assigned which may include internal and external auditing, supervisory functions, personal development, eQMS superuser and leadership opportunities.

Qualifications:

• Bachelor's degree in Engineering, Industrial, Quality or Mechanical preferred
• Minimum of 3 years relevant experience with increased responsibility preferably in a medical device organization.
• Additional peripheral experience within Manufacturing, Engineering, or Product Development is a plus
• Working knowledge of IQ, OQ and PQ techniques.
• Previous work experience in an organization that supplied large OEM’s.
• Background in GD&T

** No relocation assistance or sponsorship provided

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