QA Specialist, Commercial Quality Indonesia Surgery

Job 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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: Professional All Job Posting Locations: Jakarta Selatan, Jakarta Raya, Indonesia Job Description: Job Description Overall purpose of job: 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. Responsible for E2E support on appointed Medtech process e.g., repack/relabel, NC/CAPA, Change Control, Warehouse (DC/3PL/Distributor plus), complaint handling and support commercial quality team in execution of Quality Systems implementation and maintenance for Indonesia and LCM countries (Laos, and Cambodia) including overseeing of 3PLs and Distribution Centres in order to meet the applicable regulatory and customer requirements and Johnson & Johnson policies and standards This role reports solid line to Commercial Quality Manager, Sub Cluster Singapore, Indonesia & Philippines Surgery. Key responsibilities: Key ResponsibilitiesMaintain QMS (CAPA/NC, change control, document control, training completion) Ensure compliance with GDPMD, and local regulations Act as a TRP (Technical Responsible Person) for Indonesia (regulatory compliance, licensing) Perform investigations, root cause analysis, and audits Liaise with distributors, 3PL, and regional QA. Ensure regulatory & reporting compliance: manage adverse event / health authority reporting and timely closure per local regulations Provide QA oversight for labeling, packaging, and repack/relabel activities. Manage product quality (complaints, returns, disposition) May need to support quality management system activities for other southeast asia markets Must-Have Skills / Experience·Degree in health sciences / engineering / science Experience in QMS & medical device regulations Knowledge of CAPA, audits, and compliance systems TRP requirements (Indonesia): GDPMD training certificate issued by the MoH Strong problem-solving & communication skills Good-to-Have Experience as TRP / Indonesia regulatory PIC Distributor / 3PL quality management Required Qualification and Core Competencies for the role: Education: At least BSc. in Science or Engineer or Pharmacy or equivalent from a reputable university preferably with excellence academic background Professional Experience: At least 1 year professional experience or leading in the field of Quality Assurance, Business Quality or related functions Experience of quality audit Excellent interpersonal, leadership and quality management skill exposure to quality standard e.g. ISO, GMP, GDP, RA requirements will be desirable Experience of exposure to Regional communication Capability to communicate and good coordination and interpersonal skills Good command of written and spoken English and Bahasa Indonesia together with computer literacy Required Skills: Preferred Skills: Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment