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Johnson & Johnson

Assistant Manager, Quality Engineering

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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:

Digital Quality

Job Category:

Professional

All Job Posting Locations:

Singapore, Singapore

Job 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.

The Assistant Manager – Quality Engineering & Systems leads the Quality Management System (QMS) and quality engineering activities for the MD&D RDC. This role focusses on quality systems leadership with technical engineering expertise to ensure compliance with regulatory requirements, corporate quality standards, and industry best practices.

Ensure oversight of process quality control, validation, and continuous improvement initiatives, while acting as a key liaison between operations, supply chain, and third-party logistics (3PL) providers to optimize product quality, reliability, and distribution performance. This role is based at the Singapore Logistics Hub (SLH), MD&D Regional Distribution Centre (RDC), located in Pioneer West Singapore.

Key Responsibilities

1. Quality Management System (QMS) Leadership

  • Lead and oversee day-to-day Quality Management System (QMS) operations, ensuring compliance with GDP, GxP, ISO 13485, ISO 9001, regulatory, and corporate quality requirements.

  • Drive continuous improvement of QMS processes, including Non-Conformance (NC), Corrective and Preventive Actions (CAPA), Change Control, Document Control, Internal Audits, and Training Management.

  • Maintain a state of regulatory inspection readiness and serve as the Quality lead during internal, external, and regulatory audits and assessments.

2. Operational Quality & Compliance Oversight

  • Provide quality oversight for warehousing and distribution activities, including product receiving, quarantine management, and product release processes in partnership with third-party logistics (3PL) providers.

  • Review and approve product destructions, defect assessments, and product hold/release decisions within SAP.

  • Ensure compliance of repackaging, relabeling, kitting, rework, and temperature-controlled storage and distribution activities.

  • Lead investigations of non-conformances, ensuring robust root cause analysis, effective CAPAs, and sustainable process improvements.

3. Validation & Engineering Support

  • Serve as the Subject Matter Expert (SME) for validation and qualification of facilities, equipment, processes, packaging/repackaging operations, and distribution lanes.

  • Lead Computer System Validation (CSV), temperature mapping, environmental monitoring, and qualification programs.

  • Design and execute sampling strategies, statistical analyses, and process improvement methodologies, including Pareto Analysis, ANOVA, Statistical Process Control (SPC), and Design of Experiments (DOE).

  • Ensure validation protocols, reports, and supporting documentation meet regulatory, corporate, and technical standards.

4. Continuous Improvement & Performance Management

  • Lead quality and operational excellence initiatives across the distribution network using Lean, Six Sigma, and other process improvement methodologies.

  • Establish, monitor, and analyze quality and distribution performance metrics, KPIs, and dashboards to identify trends, risks, and improvement opportunities.

  • Develop and implement quality performance standards and evaluation criteria for logistics and distribution operations.

5. Audit & Supplier Quality Management

  • Lead and participate in internal, external, supplier, and 3PL quality audits.

  • Manage supplier and distribution partner qualification programs, ensuring timely closure of audit findings and implementation of corrective actions.

  • Ensure suppliers, logistics providers, and transportation partners consistently meet quality, compliance, and service expectations.

6. Complaint & Recall Management

  • Oversee the logging, investigation, resolution, and trending of product and distribution-related complaints.

  • Act as the backup Recall Coordinator, supporting product recall, field action, and stop-shipment activities to ensure timely and compliant execution.

7. Training, Stakeholder Engagement & People Leadership

  • Develop and deliver impactful quality, compliance, and technical training programs for internal teams and external partners.

  • Provide technical leadership, coaching, and mentorship to quality personnel in QMS, validation, and engineering-related activities.

  • Partner with cross-functional stakeholders to ensure quality strategies and programs are aligned with operational and business objectives.

Decision-Making Authority

The role is authorized to:

  • Approve NC/CAPA records, validation documentation, SOPs, and QMS-related procedures.

  • Make final disposition decisions for non-conforming materials and product release activities.

  • Approve repackaging/relabeling batch releases, destruction certificates, artwork templates, and technical change controls.

  • Place products on hold or release products within SAP based on quality and compliance requirements.

  • Recommend and implement quality system improvements to strengthen compliance, operational excellence, and business performance.

Qualifications & Experience

Education

  • Bachelor’s or master’s degree in science, Engineering, Mathematics, Quality Management, or a related discipline.

Experience

  • 5–10 years of progressive experience across Quality Systems, Quality Engineering, Validation, and Regulatory Compliance within the medical device, pharmaceutical, life sciences, or regulated healthcare distribution industries.

  • Demonstrated success in managing Quality Management Systems (QMS), leading audits and inspections, and driving continuous improvement initiatives in complex operational environments.

  • Proven ability to lead cross-functional quality and compliance programs, ensuring regulatory adherence while supporting business and operational objectives.

Technical Expertise

  • Strong working knowledge of Good Distribution Practice (GDP), GxP requirements, ISO 9001, ISO 13485, quality risk management, validation lifecycle methodologies, and regulatory expectations.

  • Hands-on experience with validation and qualification activities, including equipment, facilities, computerized systems, packaging, and distribution processes.

  • Proficiency in statistical and quality improvement tools, including SPC, DOE, Pareto Analysis, Root Cause Analysis, and data-driven problem-solving methodologies.

  • Skilled in the use of SAP, quality management systems, Microsoft Office applications, and learning or training management platforms.

Skills & Competencies

  • Strong leadership capabilities with the ability to influence, engage, and drive accountability across cross-functional teams and external partners.

  • Excellent analytical, critical thinking, and decision-making skills, with a structured approach to problem-solving and risk assessment.

  • Effective communication and stakeholder management skills, with the ability to convey complex technical concepts to diverse audiences.

  • High level of integrity, professionalism, and attention to detail, with a strong commitment to quality and compliance.

  • Collaborative and customer-focused mindset, with the ability to build strong relationships and effectively navigate a matrixed organization.

  • Continuous improvement orientation, demonstrating initiative, adaptability, and a passion for operational excellence.

Required Skills:

Preferred Skills:

Coaching, Communication, Compliance Management, Continuous Improvement, Controls Compliance, Digital Assurance, Econometric Models, Issue Escalation, Performance Measurement, Problem Solving, Process Optimization, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Compliance, Standard Operating Procedure (SOP), Technologically Savvy