Job Title: Senior Quality Engineer
The Senior Quality Engineer is responsible for managing the Quality group to achieve key department metrics and overseeing all Operational Quality Functions within the assigned areas.
DUTIES AND RESPONSIBILITIES:
1. Supervise and develop talent among Quality Engineers, Technicians, and Inspectors, focusing on compliance, issue prevention, problem solving, and team collaboration.
2. Manage performance expectations and drive accountability within the team.
3. Ensure documentation compliance with ISO 9001, ISO 13485, MDR, IVDR, QSR, and corporate requirements.
4. Oversee operational quality aspects related to product manufacturing and release.
5. Validate and qualify process and raw material changes within the area.
6. Achieve key Quality Metrics.
7. Manage QMS activities, including Deviation Management, CAPA, Change Control, complaints, audits, and related metrics.
8. Lead and support continuous improvement initiatives, such as Lean Six Sigma.
9. Ensure adherence to Quality, Corporate, and Regulatory standards.
10. Conduct Quality Risk Assessments and develop improvement plans.
11. Maintain strong communication with internal and external stakeholders.
12. Support stakeholder participation and collaboration.
13. Perform other duties as required.
Qualifications:
* Degree in Science, Pharmaceutical Quality, or a related field (BSc or higher).
* At least 5 years of experience in a similar Pharma/Biopharma role.
* Excellent communication and organizational skills.
* Proven leadership and people management experience.
* Results-oriented with a solution-focused approach.
* Strong investigative, technical, and problem-solving skills.
* Ability to work effectively within cross-functional teams.
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