Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Paranaque, National Capital Region (Manila), PhilippinesJob Description:
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 Philippines, including coordinating of distributors and suppliers in order to meet the applicable regulatory and customer requirements and Johnson & Johnson policies and standards.
Key Responsibilities
Lead the end-to-end MedTech product complaints and adverse event for the site in a timely manner and supervise related trends. Run 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, 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. Coordinate 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.
Requirements:
- Bachelor’s degree or equivalent in Science, Biology, or related field.
- 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 cultivate partnership, and influences diverse stakeholders.
- Proficiency in common softwares 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.
