- Acts as the champion for customer quality to all employees and builds a culture of customer awareness and responsiveness at all levels in the organization and act as Management Representative for the site.
- Provide vision and leadership to the overall Quality function and organisation in order to drive improvements to overall quality and compliance.
- Recruit, motivate, develop and retain team members needed to support the Quality function.
- Assess talent and skills needed to support the business and ensure appropriate skills are available
- Anticipate future needs of the Quality department, by optimizing the efficiency of the department, management of direct reports, creating and managing the department’s budget, as well as, defining and procuring space, equipment, and computer system requirements for the department functions
- Ensure that the Quality Management System meets certification body requirements and that these requirements are appropriately implemented and maintained.
- Promote the awareness of regulatory and customer requirements throughout organization.
- Represent the organization to outside regulatory bodies and liaising with outside parties on issues related to Quality.
- Participate as a member of the site management team in the development, leadership and management of the site.
- Collaborate with other departments (R&D, Operations and Supply chain, Engineering, Finance and HR) to provide guidance and resources for continuous improvement and timely resolution of issues that may impact product realization.
- Champion, lead, and support complex projects by leading cross-functional teams, actively collaborating with other department directors and managers.
- Take a leadership role in developing and implementing new techniques and initiatives and challenge people to try new approaches and to become more efficient.
- Support and drive data collection and analysis/trending for ongoing monitoring and process/product improvements.
- Ensure resource alignment and prioritization of resources to support business team and functional objectives.
- Provide internal and external audit support as necessary.
- Participate in ongoing problem solving and on corrective action teams.
- Review and approve CAPA actions in conjunction with Quality Systems.
- Develop and monitor department budgets.
- Bachelor’s degree in Engineering or Science related field.
- Minimum 10 years of quality management experience or equivalent, preferably in the medical device industry and/or FDA regulated environment.
- Solid quality engineering and systems background.
- Demonstrated knowledge and application of Design Controls.
- Demonstrated knowledge of Quality Assurance.
- Proven track record of building high performance teams.
- Exceptional leadership and technical competencies.
- Excellent communication skills, including the ability to communicate to all levels of an organization.
- Excellent analytical and problem-solving skills.
- Demonstrated ability to collaborate with cross functional teams while assuring compliance.
- Strong leadership skills, including influencing skills and team development skills.
- Thorough knowledge of QSR and ISO quality system requirements.
For an immediate interview please forward your CV using the apply button
Or call Megan Warr on 091507515 for a confidential conversation