Senior Manager, Quality Assurance

Work Flexibility: Onsite Position Summary  Establish a quality centre of excellence, develop organisational strategies, processes, goals, and metrics to drive measurable improvements in quality processes. Oversee the consistency of quality processes. Manage and address potential product and safety investigations through investigation and corrective action.  Key Areas of Responsibility Manage day-to-day quality processes to ensure issues are appropriately evaluated  Establish annual budgets and quarterly forecasts. Make necessary changes with appropriate management involvement  Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met  Develop teams to ensure timely resolution of inprocess and supplier product technical issues to avoid disruption and ensure continuity of supply   Serve as a site leader for GQO quality processes  Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations  Establish standard process to ensure appropriate resolution and management of the responsible task owner  Chair meetings required to drive closure of quality issues  Manage and provide updates for quality metrics. Implement appropriate enhancements  Represent quality processes during internal and external audits  Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets  Recruit, select, and on-board top talent  Develop talent within team to increase performance. Actively address performance issues on team  Maintain a high level of team engagement  Qualifications Knowledge Skills   Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements  Demonstrate technical knowledge of medical device product lines  Demonstrated written, verbal, listening, communication, and team-building skills  Demonstrated ability to collaborate effectively with and lead cross-functional teams  Demonstrated ability to effectively prioritize and manage multiple project workloads  Demonstrated experience with trending and analysis reporting  Demonstrated knowledge of adverse event reporting, complaint investigation, CAPA, and corrective action processes  Demonstrated leadership skills  Demonstrated process improvement and management skills  Experience with recruiting, people development  Influence across the organization    Demonstrate an entrepreneurial spirit for driving business forward- relentless drive to deliver on bold and innovative change initiatives  Increases business impact by holding self and others accountable for collaborating with global colleagues across functions and divisions, internally and externally  A predisposition for coaching and mentoring and a genuine interest in helping others develop  Strong emotional intelligence to guide how to achieve through others  Exceptional communication skills to influence key decision makers at all levels within the Organisation  Great interpersonal skills- a Team player  A strong leader with a skill for engaging their team in a common goal  Service minded and courageous  Preferred:   BS in a science, engineering or related Advanced degree preferred  Minimum of 10 years experience, 7 years of supervisory experience preferred  Masters Degree or equivalent preferred  Experience working in a regulated environment  Good understanding of manufacturing process technologies, and the ability to understand complex processes  Experience with delivering results through 6 sigma and lean methods  Strong analytical ability, relevant ERP knowledge (preferably SAP, Oracle or JDEdwards) and experience and strong PC skills (MS Excel, Access, etc.,)  #IJ Travel Percentage: 20%