Senior Manager, Quality Assurance

Position Summary

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 

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