The Director of Quality Assurance directs and coordinates all quality assurance activities within an FDA regulated design and manufacturing plant, including managing a quality assurance team working under ISO 13485. All candidates should have progressive leadership experience with developing quality systems, audit, and IQ, OQ PQ, process validation. Activities will include developing, documenting, and maintaining technical business solutions or audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and ISO 13485, ISO 149712 and 21CFR and other worldwide regulations.
typical roles and responsibilities for Director Quality Assurance
Responsible for managing quality systems in the successful implementation of highly technical or involved engineering projects in the creation and development of automatic, semi-automatic and manually controlled production processes
Manage corrective action teams and develop individual corrective action plans and systems.
Direct and manage the activities of quality and validation staff.
Prioritize quality engineering projects and assignments for completion by the appropriate QA personnel.
Establish systems to document and maintain process validation and drawing compliance.
Responsible for the performance management and career development of direct reports and their subordinates.