The Director, Quality System, reports to the Vice President, Quality. This position is responsible for the oversight of the Quality System regulatory compliance programs. This includes but is not limited to hosting Regulatory Inspections as well as third party audits and managing the site response to any adverse findings including CAPA completion on time and in full.
This role is accountable to drive the implementation, deployment & maintenance of the QMS by defining the policies and managing the Quality Manual. Define and execute improvement to the QMS with cross functional and cross-site team members.
Responsible for leading and managing the Quality Systems function to include Management Controls, Document Control, Employee Training, Internal/External audits & inspections, CAPA maintenance
Translates overall vision and values to team; establishes mid- to long-term objectives to align with company vision and accomplish organizational goals. Determines and implements best strategic direction for Quality Systems function with regard to organization, competencies, human and fiscal resource planning, quality planning and Quality Systems best practices
Represents the organization as subject matter expert with Regulatory agencies and professional organizations to ensure the Quality Management System remains current and competitive.
Develops and manages QMS planning & budget; ensures goals, deadlines, and budgets are met.
Expected to operate independently and highly autonomously; accountable to proactively fulfill tasks and achieve results within assigned timelines.
Maintain a safe, organized, and clean work environment.
Other duties as assigned
Education and/or Experience
Bachelor’s Degree in an applied science or engineering field or equivalent combination of education and work experience.
Minimum of 10 years of experience in Quality Assurance of class II or III in the medical device/diagnostics field with a minimum of 5 years of management experience
Thorough working knowledge of relevant international ISO Standards (ISO 13485, 14971) and regulations (IVDD/IVDR, 21 CFR - part 820). Direct experience working in US FDA regulated environment required
Exceptional problem-solving and organizational skills
Ability to understand and explain complex quality issues to non-experts
Knowledge and experience with EQMS/ERP/MRP systems and their applications preferred
Excellent written and interpersonal communication skills.