Manager, Quality

Position Requirements

• Bachelor’s degree in Engineering or related field with at least 10 years of Quality Engineering experience required. Contract manufacturing setting preferred.
• ISO 13485 Lead Auditor certification and demonstrates leadership of 3rd party and customer audits.
• At least 5 years of Medical Device industry experience under FDA 21 CFR part 820 and ISO 13485 requirements are preferred.
• Experience with risk management assessments and techniques, preferably in accordance with ISO 14971.
• Experience with product development, quality principles and practices, document control and working in ERP and PLM systems. Glovia, SAP, and ARAS systems preferred.
• Strong interpersonal, organizational and project management skills are required.
• Demonstrated ability to work productively with individuals at all levels inside and outside the organization, with an ability to influence key company and customer decision makers.
• Demonstrated proficiency with best-in-class data analysis tools, statistical process control software, customary PC office applications such as Word, Excel and PowerPoint required.
• Ability to travel, both Internationally and Domestically 20-30% of time.

Duties and Responsibilities

• Single point of accountability for deploying and maintaining a harmonized Quality Management System across the organization including all sites.
• Create, modify, and release Quality Procedures in accordance with FDA 21 CFR part 820 and ISO 13485.
• Drive continuous improvement of processes to ensure optimal performance of the work product.
• Establish, track, and maintain KPIs supporting compliance and operational performance of quality processes and system(s).
• Schedule, organize and lead external audits maintaining compliance with applicable standards and addressing issues or non-conformances identified.
• Schedule, organize and lead internal audits and develop quality team’s knowledge of the audit process and facilitation of 3rd party or customer auditors.
• Identify, develop, and deploy tools for the organization to support quality performance including but not limited to: software, hardware, capital equipment, aids, techniques and methods.
• Ownership of training tracking software and systems to ensure records are kept in accordance with the FDA and ISO requirements.
• Define objectives for departments to ensure quality standards are met and provide guidance where necessary to ensure the success of the department.
• Provide mentorship to Quality Team members in the areas of Quality Management, New Product Development, Corrective Actions, and other procedural ownership from the team.
• Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, FDA, US 21 CFR 820 (QSR), ISO 13485, etc.
• Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Provide strategy and structure for New Product Quality with CAPA investigations and executions in the early stages of product development including, but not limited to customer/supplier interaction, product engineering, and prototype testing.
• Report on the performance of Quality Systems to company management for review and ensure management reviews are held.
• Provide Quality Systems Leadership for the business unit and provide reports on Product Life Cycle Management, CAPA and Risk Management, etc.
• Provide consultation for the investigation of complex product problems to identify and manage corrective actions resulting from problem investigations.
• Identifies and manages risk throughout the development process with the use of FMEA formats and/or other risk management tools. This includes leading Risk management efforts of the design process and working with design team and management team on managing product and process risks.
• Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
• Promotes continuous improvement in design control activities and use of quality tools with design team.
• Serves as an escalation path to evaluate high profile quality claims and provide guidance and leadership to the team for handling the claims of non-conformance/product quality.
• Leads scheduled and impromptu audits of the quality management system as performed by registrars, regulators, and customers.