About the job
The Director Quality develops and implements the Global Quality strategy and ensures global alignment to ONWARD Medical’s Quality Management System.
As head of the Quality Team the Director Quality is responsible for the corporate Quality Management System and ensures it complies with international standards and regulations.
The Director Quality develops and implements the Quality Control as well in ARC-IM and ARC-EX programs and supports early phase projects.
Quality is an important value at ONWARD, and as such, the Director Quality has an important role in promoting the overall corporate strategy and quality awareness (mission, vision, values) throughout the organization.
Responsibilities
- Interacts frequently with internal management and senior-level representatives concerning projects, operational decisions, scheduling requirements and or contractual clarifications.
- Leads and develops the Quality Team. The Quality Team has the following responsibilities:
- Develops and implements global strategic plans which reflect in the Quality Management System (QMS), to ensure compliance with international standards and regulations.
- Develops and/or reviews standards, policies, and procedures for all internal stakeholders.
- Partners with the company’s cross-functional leadership to ensure all aspects of Product Development, Manufacturing and Distribution are performed in conformance to the quality management system and regulatory requirements.
- Develops and implements quality standard testing and evaluation processes.
- Organizes, reviews, and comprehends large volumes of complex and technical data in a condensed timeframe to ensure product safety and performance.
- Analyses and develops recommendations for actions necessary to support product regulatory submissions.
- Responsible for maintenance and improvement to the Company's QMS, in conformance with international and regional standards and regulations (ISO-13485, FDA's QSR/GMP, MDR, …).
- Ensures that systems, processes, and staffing (responsibilities and resources) are suitably designed and implemented to maintain an effective quality system together with the Quality Assurance Manager.
- Prepares, executes, and reports in internal audit and vendor management programs Reports findings to the Management Representative and Leadership Team; develops corrective action plans and procedures and ensures timely resolution of findings.
- Training of staff on quality related aspects and participation and approval of necessary quality investigations including non-conformities and corrective and preventive actions.
- Liaises directly with notified body and other regulatory and competent authorities.
- Together with the Leadership Team, defines, monitors and trends relevant KPIs and quality metrics in line with established quality objectives and ensures that Quality meets or improves on targets.
- Cross functional collaboration across the organization for transfer of best practice and implementation of improvements.
- Establishment of quality-specific documentation in cooperation with applicable departments (e.g. Quality Plan, Risk Management Plan, Quality Agreement, Validation Master Plan).
- Leads quality representatives for regulatory inspections.
- Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements.
- Periodically reports status of quality control and operations to executive leadership and, when required, regulatory agencies.
- Supports post market surveillance activities.
- Supports GDPR and HIPAA compliance within the organization.
