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The Role
As a Senior Quality Engineer, you are responsible for managing the applicable Quality group to deliver on achieving all key department metrics while also overseeing all Operational Quality Functions within the assigned areas.
DUTIES AND RESPONSIBILITIES:
1. Supervision and talent development of Quality Engineers, Technicians and Inspectors with focus on compliance, issue prevention, problem solving, and team working ethic between department functions.
2. Manage performance expectations for Quality Engineers, Technicians and Inspectors and drive accountability.
3. Responsibility for ensuring that documentation is compliant with ISO 9001, ISO13485, MDR, IVDR, QSR and corporate requirements as applicable.
4. Responsible for all operational quality aspects associated with product manufacture and release within the assigned area.
5. Responsible for the successful validation and qualification of process and raw material changes within the assigned area.
6. Ensures key Quality Metrics are attained.
7. Management and oversight of the QMS related activities incl but not limited to Deviation Management, CAPA, Change control, complaints, audits, related metrics etc.
8. Leads, supports and implements continuous improvement/lean 6-sigma initiatives.
9. Ensures pertinent Quality and Corporate and Regulatory standards are attained.
10. Perform appropriate Quality Risk Assessments and develops plans to deliver quality improvements within the area of responsibility.
11. Maintains strong communication with internal and external stakeholders.
12. Participates/supports the internal/external stakeholders.
13. Other duties as required.
Who You Are
1. Degree in Science, Pharmaceutical Quality or similar (BSc or higher)
2. 5 years previous experience in a similar role (Pharma/Biopharma)
3. Excellent communication and organization skills
4. Strong and demonstrated people management, colleague development and leadership experience
5. Results oriented and solution focused
6. Excellent investigative and technical ability and excellent approach to problem solving.
7. Collaborative with a demonstrated track record of working successfully within a cross-functional team
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