Commercial Quality Executive

8 hours ago

Petaling Jaya, Malaysia Johnson & Johnson Full time

Johnson & Johnson (J&J) MedTech is a provider of medical devices and diagnostics products to the market. It ensures that its products and services are scientifically sound and of high quality to help heal, cure disease, and improve the quality of life of patients and consumers. The Johnson & Johnson Commercial Quality department provides quality oversight and support to the local operating companies in the areas of strategy and planning, quality system oversight, compliance reporting, portfolio and product lifecycle management, product supply, and distribution.

This role reports solid line to the Commercial Quality Manager, MedTech Singapore, Malaysia & Philippines.

This role is responsible for the site management and execution of Quality Systems establishment, implementation and maintenance for Malaysia and Brunei, including overseeing of 3rd party logistics, and service center in order to meet the applicable regulatory and customer requirements and Johnson & Johnson policies and standards.

KEY RESPONSIBILITIES Manage the end-to-end MedTech product complaints and adverse event reporting for the site in a timely manner and monitor related trends. Manage the overall activities related to escalations, field action, and stop shipment applicable to the site. Lead audit readiness activities for external inspections and internal audits for the site, including audit response. Coordinates Quality System Management Review meetings and key quality metrics reporting, which includes Non-conformance, CAPA, Complaints, Change Control, Audit Actions tracking and monitoring as per timelines. Support and ensure site compliance to GxP training plan for quality system elements covered by the site’s quality manual. Oversee activities related to Supplier/Distributor lifecycle management (qualification, audits and disengagement).

Supports the following operational activities related to MedTech segment with cross functional stakeholders:

- New Product introduction
- Product Change management
- Labeling and Packaging
- Product discontinuation
- Change control
- Document control
- Non-conformances and CAPA
- Product inspection and release
- Temperature excursion
- Trade return disposition
- Installation and Servicing quality oversight

Support projects and duties as assigned by manager.

**Qualifications**:

- Bachelor’s degree or equivalent in Science, Biology, or related discipline.
- Minimum 3-4 years of experience as a quality assurance personnel or related role.
- Proficiency in written and spoken English.
- Requires knowledge and understanding of industry and regulatory standards and overall quality management system (QMS).
- Good interpersonal and communication skills that fosters partnership, and influences diverse stakeholders.
- Proficiency in common software such as Excel, Word, PowerPoint. Ability to learn and master the various systems used manage activities and data related to Johnson and Johnson QMS.
- Agile and able to work independently and achieve objectives related to assigned responsibilities.

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