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 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%