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Quality Systems Manager – Sartorius Corporation – Yauco, PR

The quality System Manager oversee customer complaint analysis and introduce problem solving solutions. Supervise key performance indicators (KPIs). Manage KPIs based meetings to ensure quality focus, streamline and measure results for continuous improvement. Manage the Equipment and instrument calibration program. Responsible for Customer Audits, corrective and preventive action based on the audit outcome.

The quality System Manager oversee customer complaint analysis and introduce problem solving solutions. Supervise key performance indicators (KPIs). Manage KPIs based meetings to ensure quality focus, streamline and measure results for continuous improvement. Manage the Equipment and instrument calibration program. Responsible for Customer Audits, corrective and preventive action based on the audit outcome.


Main Responsibilities & Tasks:

1. Manage Costumer Audits

2. Ensure that any costumer observation is canalize through the responsible department ensuring the on time closure

3. Responsible of maintaining the company certification such as ISO 9001 and RX-360

4. Manage the Document control and Complaint group

5. Ensure Complaints are closed on time following company quality standards

6. Manage the calibration program of the Yauco site

7. Identify opportunities areas to minimize waste and enhance efficiency.

8. Help and support customer as well as employee satisfaction study and improvement.

9. Design, develop and maintain quality control goals and objectives.

10. Coordinate established objectives with production methods cooperating with manufacturing to increase product reliability and reduce costs.

11. Manage customer corrective activities to ensure thorough and timely response.

12. Develop and implement achievement strategy for “0′ customer complaints.

13. Manage KPI’s too ensure quality focus , streamline and measurement results for continuous improvement.

14. Manage the CAPA and NCPR metrics and propose actions plan to reduce the quantity of NCPR and CAPAs


Qualifications & Skills:

At least 10 years of experience in GMP environment, preferable in Medical Device CFR 820.

At least 5 years of supervisory experience.

Direct experience managing Quality Systems.

We look for employees who would like to grow with us and move the innovative life sciences sector forward. In the process, we focus on agile project work, mutual support within teams and working as equals. Sartorius thrives as a company with people who give their very best every day and who are eager to develop personally and professionally.

Further insights into our world of work can be found here.

Source: Indeed.com
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