Quality Systems Lead
On-siteSan Cristóbal, San Cristóbal, Dominican Republic
Job Summary
Lead quality system development, maintenance, and compliance with FDA, ISO 13485, and ISO 9001 standards across site operations. Manage department activities including document control, training, corrective actions, change control, supplier audits, and electronic system validation. Ensure software implementations comply with applicable regulations and lead follow-up on regulatory agency submissions and ISO registrar issues. Support marketed products by reviewing engineering changes, labeling, and documentation requiring government approval. Propose quality system improvements, develop business continuity plans, and establish metrics for local teams and global business units. Close systems timely while facilitating resource discussions with stakeholders. Manage expenses, support budget planning, and provide guidance on safety, health, and environment programs. Maintain accuracy of regulatory contact logs and direct report matrices.
Required Qualifications
- Quality Systems and Compliance programs subject matter expert
- Quality system development, effective maintenance and continued compliance with business unit requirements
- Medical device regulations and standards knowledge (U.S. – FDA, ISO 13485, ISO 9001)
- Document and Data Control
- Retain and Records Retention
- Training
- Corrective and Preventive Action
- Change Control
- Deviation
- Supplier Audits
- Supplier Corrective Action Requests
- Electronic System Development/Validation
- Management Review
- Complaint and Feedback process
- Product Release
- Auditing
- Agency Inspections
- Quality Improvement Initiatives
- Regulatory contact and submission log maintenance
- Regulatory guidance to internal project teams
- Software implementation review, validation and compliance with applicable standards and regulations
- Follow-up, negotiation and resolution of issues regarding current and future submissions with appropriate regulatory agencies and ISO registrars
- Local and national regulatory knowledge development
- Support of currently marketed products including review of engineering changes, labeling, promotional material, product changes and documentation of changes requiring government approval
- Quality System improvement opportunities proposal and execution
- Business Continuity Planning programs development and maintenance
- Writing, reviewing and approving validations in accordance with customer and regulatory requirements
- Quality System metrics establishment, maintenance and reporting to local level teams, management and global business units
- Systems closure including adherence to all in-process milestones
- Prioritization and resource discussions with Change/Improve and other stakeholders
- Collaborative work with other stakeholders to ensure effective and compliant processes
- Expense management
- Budget planning support
- Site wide process improvement opportunities support
- Alignment with Jabil Corporate Code of Ethics, Corporate and Global policies, Employment Labor Laws, Health Regulatory Agency Regulations, and Safety Requirements
- Matrix generation / updating / maintenance for direct reports
- Support to all Safety, Health and Environment (EHS) programs and initiatives
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