HC Quality Support Center Specialist
hace 2 días
Job Title: HC Quality Support Center Specialist
Job Description:
The HC Quality Support Center Specialist will oversee the performance and activities within the HC Quality Support Center. This role communicates the quality policy and objectives to ensure alignment with healthcare guidelines and ISO 9001/ISO 13485 requirements. The specialist develops standard operating procedures, reviews and approves work instructions, and trains personnel on SOPs and regulatory topics. This position assesses trends and communicates recommendations to senior Quality Leadership.
Responsibilities:
- Develop and manage quality records in alignment with the quality policy and processes.
- Manage the Quality System Training Program.
- Manage validation documents and review testing of changes to validated systems.
- Manage reviews of policies, procedures, regulations, and work instructions.
- Develop trending criteria for quality data to assist with performance trending.
- Participate in regular internal and external meetings and management reviews.
- Provide training, support, and developmental opportunities to direct reports.
- Manage resources and people processes to ensure day-to-day administration of processes and formal procedures.
Preferred Competencies:
- Knowledge of different regulations and ISO 9001/ISO 13485 standards.
- Advanced English language skills.
- Strong project management skills.
- Strong analytical and people management skills.
- Good knowledge of a Quality Management System and electronic Management System.
- Good knowledge of Microsoft Office.
- Ability to create networks and collaborate with various stakeholders.
- Ability to prioritize decisions with significant risk for the company.
- Identify potential gaps in processes and make recommendations for improvements.
- Strong time management skills.
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