Job Title:  Manager, Quality

 Summary of Position

The Quality Manager role provides support and leadership to ensure the successful execution of procedures and product quality across the organization including control of documentation. The role applies knowledge of Quality Management System in compliance with ISO 13485 and FDA 21 CFR part 820 requirements as well as Medical Device industry practices to positively influence the organization’s quality performance and continued compliance.  In parallel, this position shall ensure procedures are harmonized and trained across all sites and key metrics are established indicating product and process quality are executed in accordance with the QMS, applicable industry standards, other regulatory requirements, and customer requirements.  This role will also be a consulting resource for the review and evaluation of scientific methods and technical data as it pertains to product quality and product testing leading teams to identify and solve complex product and process problems.

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.
• Other duties as assigned or required.