[MedTech] Senior Commercial Quality Analyst

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:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
TW009 One J&J Taipei

Job Description:


* Documents business critical issues in Customer/Commercial Quality and tracks regulatory changes.


* Applies in-depth knowledge of Customer/Commercial Quality and surfaces policies that may impact organizational objectives.


* Conducts routine collection and dissemination of feedback to ensure continuous improvement of the quality management system.


* Completes processes to ensure internal organization's alignment with overall quality priorities.


* Implements formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems.


* Analyzes complex research and data related to regulatory changes, external trends, and strategy.


* Contributes to customer handling complaint process, and establishes and maintains Quality System Elements.


* Coaches more junior colleagues in techniques, processes, and responsibilities.​


* Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

The main responsibilities are as following in accordance with execution of the Quality Management Systems and compliance, which involve change control, repack/relabel tracking, complaint handling, and reporting serious adverse events.


* Support the implementation and maintenance of the Quality System to ensure awareness and continuous education across the local organization.


* Coordinate with stakeholders, establish and drive the execution of corrective and preventive actions, ensuring the timely closure of CAPA actions, including those involving 3PL DC.


* Consolidate and track quality compliance metrics, identify and analyze gaps with targets, recommend initiatives for continuous improvement of quality performance, and enforce compliance.


* Serve as a subject matter expert and provide training to the country on the quality system, auditing behaviors, complaint vigilance, and process improvement methodologies, techniques, tools, and language to enhance processes and improve business results.


* Drive the execution of complaint vigilance and pharmacovigilance in the country, ensuring the timely closure of product-related complaint cases and Adverse Event reporting.


* Ensure the material & product control within DC, ...