JOB OVERVIEW:

This position is responsible to develop and implement systems to ensure products or services are designed and produced to meet or exceed customer expectations and regulatory requirements including the US Food and Drug Administration, Health Canada, European MDD/MDR and others as required.  This role will also participate in the implementation of improvements to the company’s quality management system procedures including Nonconformance Material processes, Customer Complaint handling, Supplier Management, Process Validation, Measurement Systems Analysis and other quality engineering duties.  This role will also be responsible to directly contribute to the implementation of the company’s quality system processes related to CE Technical Files, including Risk Management Files, Clinical Evaluations, Post Market Surveillance and Periodic Safety Reports.  In addition, this role will be responsible to perform and mentor others in performing thorough Root Cause Analysis, Corrective Action planning and implementation and Verification of Effectiveness planning and implementation.  This Corrective Action process will apply to internal nonconformities, product complaints, supplier quality issues, and will also provide engineering analysis and support in verification, validation and problem solving.

KEY RESPONSIBILITIES: 

• Engages in continuous improvement activities by identifying opportunities and recommending improvements to product design and manufacturing processes.  Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes and CAPA investigations.
• Drives supplier quality improvement by providing engineering analysis related to component specifications and root cause analysis.  Partners with key suppliers and manufacturing personnel to reduce defects and improve yield.  Participates in supplier selection and qualification processes, including supplier quality audits.
• Develops processes for the effective generation of metrics, including established Key Process Indicators, for use within the Quality Department.
• Conduct periodic trend analysis and provides business impact analysis of product and process trends to monitor and take appropriate corrective/preventive actions to ensure product quality, patient safety and compliance with regulatory reporting requirements.  Implements problem solving methodologies to reduce internal and external defects.
• Provide quality engineering insight and guidance on product development, product improvement and process improvement projects.  Ensures validation of key design inputs including usability, reliability, performance, manufacturability, safety and effectiveness.
• Plan, control and assure product and process quality in accordance with quality principles and best practices, including process planning, material control, acceptance sampling, measurement systems and process validation.  Identifies and implements product and process controls consistent with the outcome of the risk management process.
• Maintains knowledge of relevant quality and regulatory standards and augments quality system processes to meet changing requirements, including the Medical Device Regulation, US FDA, MDSAP and others as required.  Creates technical documentation and reports to support regulatory requirements, including Clinical Evaluation Reports, Post Market Surveillance Reports, Periodic Safety Reports and other analysis as required.
• Supports computer system validation and stays current with validation regulatory requirements.
• Participates in special projects and perform other duties as required.

KNOWLEDGE: 

Senior level professional; knowledge and full understanding of one or more disciplines and good knowledge of organization, processes and customers. Good judgment, strong analytical ability, evaluation, originality and ingenuity required to perform tasks. Know and apply the fundamental concepts, practices, and procedures of a particular field. Resolve issues and assignments in creative ways. Some assignments may be broad in nature. May serve as a resource to others to resolve complex problems and issues. May take on project co-lead role as required. 

COMPLEXITY: 

Work on problems of diverse scope and moderate impact where analysis of data requires a review of a variety of factors. Use best practices and knowledge of business strategy to solve complex problems; recommend solutions to business challenges. Demonstrate good judgment in selecting methods and techniques for obtaining solutions. Network with senior internal and external personnel in own area of expertise.

SUPERVISION: 

Receive minimal instruction on day-to-day work and general instruction on new projects or assignments.  May act as a resource to provide informal guidance for TSMs with less experience. Assignments can be broad in nature.