Basic Functions:

Under minimum supervision manage and improve quality performance from Fresenius Kabi suppliers. Develop, coordinates and implement quality and reliability improvement projects. Assume a lead role in supporting and follow-up solutions to existing or potential supplied component related problems affecting the San German operations. Serve as technical liaison between suppliers and appropriate Fresenius Kabi representatives. Perform supplier audits and provide follow up for observations closure. Develop and submit quarterly supplier performance data for the San Germán facility management. Develop and represent Supplier Quality metrics at site management review meetings, monthly quality meetings and Product Review Meetings (PRMs). Comply with all regulatory requirements, including FDA, EHS & ISO standards. SCAR/ICAR system administration. Ensure Data Integrity procedures are followed including good documentation practices.

Task & Responsibilities:

1. Identification, analysis and feedback of component related issues at Receiving Inspection, manufacturing processes and at customer level. Lead root cause analysis team.

2. Lead suppliers in corrective and preventive actions identification and implementation at the external/internal supplier level, via the SCAR/ICAR system.

3. Active role in driving supplier certification program improvements.

4. Support Process/Product Quality Engineering groups in the development and implementation of inspection and testing methods for Receiving Inspection and suppliers.

5. Responsible for the Supplier Quality Qualification Program. Schedule, develop, plan, perform and report the regulatory quality systems audits for the manufacturers and providers of supplied products to Fresenius Kabi.

6. Conduct timely corrective actions follow up until proper closure of each supplier audit is achieved.

7. Ensure robust, timely supplier related investigations.

8. Support identification, recommendation and implementation of component quality and reliability improvement projects.

9. Review component specifications, where necessary.

10. Support, review and approve mold approval validations.

11. Manage the quality aspects of qualification and utilization of service and software suppliers

12.Assure investigations are initiated and performed on a timely manner.

13. Conduct supplier quality audits.

14. Regulatory compliance with our environment, energy, health and safety policy.

15. Other responsibilities as assigned by the Supervisor.

Requirements:

· Excellent written and verbal communication and presentation skills in English and Spanish.

· Computer literature required (spreadsheet, word processing, statistical software)

· Knowledge in Statistics and Six Sigma concepts.

· Thorough knowledge of all documentation processes.

· Good organizational and interpersonal skills (teamwork oriented) are required.

· Self-starter and multi-tasking oriented

· Must be knowledgeable on QSR/OSHA/ISO 13485/ISO 14971/MDD requirements and Canadian Medical Devices Regulations SOR/98-282.

· Willing to travel

Education Required:

· Bachelor degree in science or engineering.

Experience:

· Preferable with experience in pharmaceutical/ medical device manufacturing environment.

Job Type: Full-time

Schedule:

• 8 hour shift

Ability to commute/relocate:

• San German, PR 00683: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Pharmaceutical / Medical Devices: 2 years (Preferred)

Work Location: In person

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