Director Quality Assurance
Purpose
Leads QMS system administration and enhancements of the Foot and Ankle facility in France, actively ensure leadership and participate in global improvement initiatives. Ensures compliance to FDA Quality System Regulations, ISO13485 standards and international standards and regulations for all quality system processes and procedures. Directs Quality Assurance and Quality Engineering activities to foster a culture of continuous improvement as well as ensuring that all manufacturing processes conform to documented requirements.
Leading special projects international in the field of Quality Assurance and Regulatory Affairs in order strive for QMS harmonization and Regulatory Registration excellence.
Key Duties and Responsibilities
Management of the In2Bones Quality team – 50%
- Provides leadership and direction in the development, implementation, and maintenance of the methods used to assure quality system compliance to FDA QSR and ISO13485 requirements.
- Functions as an influential leader driving compliance within direct teams as well as across the corporation.
- Provides direction within the Quality Systems group, establishing appropriate goals and setting priorities for the group.
- Provides direction and support for the CAPA process to ensure effective root cause corrective action is implemented to address nonconformance.
- Directs the Quality Systems departmental budget, ensuring a high level of fiscal responsibility within the organization.
- Provides adequate budget to ensure Quality Systems personnel are adequately trained and requirements are met to service the business.
- Ensures supervision of personnel in the Quality Assurance group (both direct and indirect reports) is conducted in a fair and consistent manner.
- Host and be responsible for all government inspections and QS Audits.
- Provides direction to support internal and external audits.
Program management of special programs International
- Leading the APAC control tower program in order to speed up time to market for product registrations in the APAC region.
- Develop and maintain international metrics for quality assurance and regulatory affairs
- Leading projects to harmonize international quality system management
In addition to the main responsibilities listed above the manager is allowed to USE discretion TO add further duties and tasks based on the business needs which are not explicitly listed here.
JOB REQUIREMENTS
INIMUM REQUIREMENTS
Education
- Bachelor’s degree in Engineering or related discipline
Experience
- Minimum 10 years’ experience in Manufacturing/ Quality Assurance environments and with at least 5 years in Medical Device or other FDA regulated industries.
- 5 Years in management role.
- A proven track record of success in implementing and maintaining quality systems.
Other Attributes
- Proficient knowledge of QSR/ISO and Global requirements.
- Strong working knowledge of quality assurance and Manufacturing principles and practices.
- Language skills: good written and verbal English and French communications skills required.
- Passion for quality and to do things rightTrack record of leading international projects
REFERRED REQUIREMENTS
- Proven track record of successfully building and developing teams in a matrix organization.
- Demonstrated ability in effectively interacting and partnering with different business functions.
- Quality Certifications (CQM, CQE, CQA, or Lead Assessor)
- MBA or Master's degree
