Supplier Quality Engineer
Merck Sharp & Dohme Corp.
, CL, Spain, Burgwedel
hace 33 días

Description

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-

year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD is recruiting a Supplier Quality Engineer. The scope of this position includes suppliers that provide Purchased Materials to MSD Animal Health sites.

This role will be :

Responsible for serving as a primary point of contact for high risk and escalated suppliers for MSD sites.

Will function within one of five categories (i.e. primary packaging, secondary packaging, glass, product contact, or raw materials).

Will provide cross-category support to support surges in workload.

Responsible for implementing procedures and best practices supporting MSD's SD&PM organization, under the direction of the Supplier Development and Performance Management (SD&PM) Associate Director.

The incumbent will exercise leadership in monitoring and maintaining supplier compliance with worldwide regulatory requirements, current Good Manufacturing Practices (cGMPs), MSD Manufacturing Animal Health Quality Manual, Quality Management Systems (QMS), and pertinent legal and / or business contract requirements.

Key responsibilities include leading supplier deviation investigations, upskilling suppliers for Quality, Compliance and Regulatory improvements, and interfacing with MSD sites.

The incumbent will assist the SD&PM Associate Director in driving completion of Supplier Improvement Plans with suppliers and interfacing with MSD site Operations, Quality, Planning, Global Procurement and Global Technology Operations colleagues.

The incumbent will possess Analytical, Scientific, Technical, Manufacturing, and / or Quality experience in order to effectively administer and control Quality and Technical programs and projects needed to manage suppliers, under the direction of the SD&PM Associate Director.

Primary Roles include, but are not limited to :

1. Travels up to 50% of the time, to and from supplier sites and MSD sites within the region.

2. Serves as a primary point of contact to MSD sites and suppliers in the region.

3. Assigned to either the Glass, Primary Packaging, Secondary Packaging, Product Contact, or Raw Materials categories, but will provide cross-

over support to all of the categories, as needed.

4. Responsible for coordination, oversight and communication on matters related to the regulatory or ISO status with the suppliers.

Must understand worldwide regulatory requirements and current Good Manufacturing Practices.

5. Acts as a liaison between suppliers and internal MSD site personnel.

6. Travels to and from supplier locations to resolve Manufacturing, Quality, Technical and supply issues and investigations, as well as facilitates overall Quality improvements to proactively prevent supplier issues.

Utilizes enhanced problem-solving skills to determine true root cause and development of irreversible corrective actions.

7. Develops and executes Supplier Improvement Plans (SIPs) for Constant Care suppliers and supports SIPs for Critical Care suppliers.

8. Coordinates, communicates and oversees general technical matters pertaining to suppliers, including understanding and optimizing component / material usage and upskilling suppliers to provide improved materials and services.

9. Provides efficient and effective solutions and Corrective Actions / Preventative Actions (CAPAs) to suppliers and / or site issue resolution, including Deviation Management, response to supplier audit issues, and customer complaints.

10. Provides supplier investigation ownership using tools such as the Supplier Escalation Report (SER) and communicates results in weekly Tier meetings.

11. Provides technical inputs, review, and execution of Quality Agreements.

12. Tracks and monitors supplier operational and quality performance. Escalates issues to the SD&PM Performance Management Associate Director and site personnel.

13. Assists in development and delivery of supplier metrics and scorecards.

14. Participates in periodic business review meetings with suppliers.

15. Works at a MSD site and provides SD&PM support to the MSD site.

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