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.,)

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Travel Percentage: 20%