Quality Systems / Quality Compliance Manager
The primary function of the Quality Systems / Quality Compliance Manager will be to;
- Implement and ensure Quality System Compliance according to ISO 13485
- Set direction and identify priorities of the Compliance to regulatory requirements.
Reporting to Plant Manager, you will be responsible for:
- Implement and ensures compliance to the quality requirements set in ISO 13485, GMP and corporate quality system.
- Lead site personnel in the maintenance of compliance levels according to ISO13485
- Leads the Documentation Control and Change Control processes
- Leads Regulatory Affairs. Provide leadership and guidance in the implementation of regulatory strategies and plans to ensure currency of device Technical files and Design Dossiers
- Lead the Validation process
- Leads the Management Review process
- Leads the internal audit and supplier quality processes
- Leads the Sterilization process
- Takes lead on assigned cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations.
- Set direction and identify priorities of the compliance requirements
- Assign resources and responsibilities.
- Provide leadership and development of the organization to maximize effectiveness and assist development of employees of the Compliance and validation functions
Review & Evaluation
- Implement and ensure compliance to the quality requirements per the site, GMP and corporate quality system ensuring all procedures and policies are up to date.
- Integrates corporate requirements and promotes synergy/consistency with other sites.
- Ensures a proactive evaluation of regulatory, compliance and quality issues and integrates them into the QMS on a priority basis.
- Responsible for leading continuous improvement projects including creation, scoping and implementation.
- Participate as a key member of the departmental staff team contributing to the overall effectiveness of the business.
- Project manage and schedule key projects and initiatives ensuring timely execution and goal achievement.
- Implementation of lean manufacturing philosophy and six sigma principles to eliminate waste.
- Represents company on corporate wide initiatives and teams as requested.
- Report pre-defined KPI’s on a weekly basis and assist in developing the quality metrics.
- Demonstrates through management style respect for the core values and a commitment to teamwork and communication.
- Trains employees on areas of expertise.
- Develop the skills of the employees of the department, ensuring they are trained in all duties required.
- Develop staff on new quality initiatives and assist in the understanding and rollout of quality initiatives across the department/site.
- A level 8 Degree in a Quality, Science or Engineering discipline
- Excellent working knowledge of Quality System Requirements such as ISO 13485, MDSAP and 21 CFR 820.
- 5 – 8 year’s experience working in the Quality Department of a Medical Device/Pharmaceutical or Healthcare company.
- An understanding of SAP is an advantage
- Organized with a proven ability to achieve targets.
For a confidential discussion and more information on the role, please contact Davin Ferguson on 071-9140251 or email firstname.lastname@example.org