CQ Lead, Malaysia

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Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Petaling Jaya, Selangor, Malaysia

Job Description:

DePuy Synthes is recruiting for a CQ Lead, Malaysia, located in Petaling Jaya, Malaysia.

This role is responsible for the site management and execution of Quality Systems establishment, implementation and maintenance for Malaysia, including overseeing of Suppliers and Distributors, in order to meet the applicable regulatory and customer requirements and DePuy Synthes (DS) policies and standards.

Essential Job Duties and Responsibilities

Site quality management system activities:
1.

Acquisition and divestiture:


* Provides quality support for acquisition and divestiture activities, including change control.

2.

Adverse event and/or Health Authority reporting (where applicable)


* Responsible to report adverse events/product quality issues are reported to the health authority in the site if required by local regulation, and ensures robust processes are in place for timely reporting and closure.

3.

Audit Readiness, including Inspection management:


* Ensures compliance and audit-readiness of site to DS Quality Policy Standards and applicable local regulatory requirements (i.e.

GDP and GDPMD).Lead as site SME for inspection management by coordinating activities related to pre- and post- audit including providing briefing and guidance to all cross functional team, managing audit arrangement and lead in audit response to auditor.

4.

Change Control


* Lead for site's change control management.

Responsible to ensure process is followed and records are managed in a timely manner with proper impact assessment, monitoring are taken.

Monitors related metrics and initiates actions for improvement

5.

Complaints management


* Lead the end to end complaint management for the site.

Responsible to prepare and sign customer resolution letters when requested by complainant.

Monitors trends, related metrics and initiates actions for improvement.

6.

Combination product


* Ensures local regulations and DS standards related to combination products are met.

...