Assistant Manager, Quality Engineering

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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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

• Bachelors or masters degree in science Engineering Mathematics Quality Management or a related discipline.

Experience

• 510 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.

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