COMMERCIAL QUALITY SENIOR SPECIALIST [VISION CARE]

About Johnson & Johnson 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.
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Responsible for maintaining and effectively implement quality management system in Hong Kong and Taiwan markets as per Vision (Vision Care and Surgical Vision) Quality Management System (QMS) and applicable local regulations.
Take part in external audit, conduct second party supplier audits within and outside designated markets; coordinate with the team on post-auditing activities.
Responsible for facilitating the nonconformance resolution process, and execution of corrective action and preventive action, ensuring the timely closure of Corrective Actions and Preventive Actions (CAPAs).
Manage relationship with Third Party Logistics (3PL) / Regional Distribution Center (RDC) Providers and Service providers through evaluating, monitoring their quality and compliance activity especially in processes such as complaint vigilances, Repack/Relabel process etc.
Assist in complaint handling whenever applicable and administer the field action execution in compliance with company and local regulatory requirements.
Adheres to environmental policy, procedures, and supports department environmental objectives.
Duties & Responsibilities · Implementation and maintaining the Quality Management System and ensure the overall effectiveness of the system involving cross markets level.
· Manage Third Party Logistics (3PL) / Regional Distribution Center (RDC) for cross segments.
· Support and conduct audits activities as applicable including internal, suppliers (not limiting to DC/3PLs), external and distributor.
· Follow up and coordinate with cross functional team on post auditing activities and drive NC /CAPA activities till closure.
· Track on quality compliance metrics, identify, analyze gap, recommend initiatives for continuous improvement and compliance enforcement.
· Support and coordinate on site management review.
· Support on post market surveillances activities on a timely manner not limited to Field Action, Recall, Medical or Adverse Event reporting.
· Support on document control system and training system.
· Support cross functional product release activities at the regional distribution centers as required including inspection and over labeling/rework.
· Accountable for Quality management of repacking, relabeling, over labeling, kitting, reworking and loan kit operations conducted within the DC.
· Support on project assignment/initiatives from the line manager.
· Support/lead activities, projects and initiatives to integrate information from compliance audits and assessments and regulatory trends.
· Identify, escalate regulatory, compliance, and quality issues to management.
· Ensure applicable relevant internal standards and processes across the business without compromising customer expectations.
· Performs other ad hoc related tasks as required.
Qualifications Experience & Education · University / Bachelor Degree or equivalent or more than 5 years of experience in medical device industry.
· 4 -5 years working experience in technical / quality / regulatory role in the Medical Device or GxP regulated Industry.
Or prior experience with ISO or equivalent quality standard program.
Required Knowledge & Skills • Good knowledge of Good Distribution Practices (GDP), GMP and validation - demonstrated knowledge and application of ISO, ISO and other international standards.
• Demonstrated knowledge and experience in quality or operations function.
• Knowledge of manufacturing environment or repackaging/relabeling environment • Familiar with basic quality tools.
Ability to execute quality system programs & audits • Demonstrated ability to handle multiple projects.
Proactive team player, able to take charge and follow through.
• Task oriented with proven experience in the delivery high quality work.
• Excellent analyzing / decision making / problem solving ability.
• Fluency in English is required.
• Proficiency in Microsoft Office (PowerPoint) other tools required to develop training materials.
This Is What Awaits YOU At J&J An opportunity to be part of a global market leader.
A dynamic and inspiring working environment.
Many opportunities to work on challenging pro jects and assignments.
Possibilities for further personal as well as professional development.
Many employees benefits.
Supportive team culture, flexible working hours, employee development and wellness support, Refreshment in the workplace, company gym, JJ Club, corporate events Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.