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.,)
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Travel Percentage: 20%