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QUALITY ENGINEERING MANAGER,ASIA PACIFIC
Requisition ID: 1805629938W
Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We welcome innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every single day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives
In India, J&J operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices, which are independently handled and report into their respective Global business segments
J&J Medical India (JJMI) is the market leader in the Medical Company Devices Industry in India. It is in the business of caring and providing solutions to doctors, patients and nurses. It comprises of multiple Franchises (Strategic business units) providing healthcare solutions across Vision Care, Orthopaedics, Infection Prevention, Wound Management, Women’s health, minimally invasive surgery, Circulatory disease management, and Blood glucose monitoring and insulin delivery.
The J&J Supply Chain is an integrated, global supply chain that serves the needs of the 1 billion people who use J&J products every day around the world. We manufacture more than 26 billion product units per year, from raw component sourcing to end product distribution as efficiently and effectively as possible with high quality, compliance and service performance. Our supply chain organization makes up 45% of all J&J employees, and includes 125 internal manufacturing plants, manages 581 external manufacturers, utilizes 459 distribution centers, partners with over 3700 direct suppliers, produces over 300,000 sku’s
The Global Job Posting policy promotes the dedication to the advancement and development of our employees. We invite you to read this posting and apply if you are passionate about the position and meet the requirements.
The Quality Engineering Manager plans, directs, and conducts projects of major scope and significance to the Company with full technical responsibility for interpreting, organizing, executing and coordinating assignments. They may contribute inventions, new designs or techniques which are materially significant in the solution of important problems. Quality Engineering Manager will act as a mentor to more junior staff and advise top management on technical matters.
The Quality Engineering Manager will utilize Quality Engineering tools and methods for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision. He/she will ensure effective risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in Base Business and supervise, lead and mentor other engineers and technicians across multiple sites and/or various geographic regions.
- Lead and/or support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Establish metrics that are leading and lagging indicators of quality
- Supports the development of quality engineering, compliance and leadership talents with the right skill sets for new product introduction and product life cycle management.
- Establish Quality cost categories and Quality cost bases
- Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
- Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
- Conduct periodic line audits to assess adequacy of production controls. Review results of audits to ensure that corrective/preventive actions are adequate.
- Establish and maintain department/cost center budget
- Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
- Supports the development of quality strategies related to the transfer of products, materials and components within J&J or externally. Supports NPI’s as part of design transfer.
- Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others (including Quality Engineers and Technicians) across multiple sites and/or various geographic regions.
- Lead and maintain Material Review Board.
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
- Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
- Approve IQ, OQ, PQ, TMV or Software Validation
- Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
- Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan
- Owner of measurement systems and capabilities, destructive tests, non-destructive tests for manufacturing processes and sampling plans protocol development and execution.
- Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. Standardize and develop methods/techniques of analytical/statistical analysis and interpretation.
- Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether potential non-compliance to a required standard.
- Assess the need for risk mitigation techniques given product classification.
- Ownership and accountability of risk assessment process including conducting, documenting, reviewing or maintaining current risk and hazard analysis documentation such as Process FMEAs given product/process changes
- Collaborates with other quality leaders to identify required quality engineering skills and competencies to allow for the execution of the strategic vision.
- Conduct strategic planning with site leaders and Product Engineering Team. Partnership with other functions to establish business priorities and resource allocation
- Ensures effective quality strategies are created for test methods validation, process and design.
- Generally requires 5-8 years related experience including 2-4 years specific experience in a management/supervisory role.
- Experience working in both an FDA, European and Indian MDA regulatory environment is preferred.
- This position will require relevant experience working in manufacturing/operations.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Experience with a proven track record of implementing appropriate risk mitigation.
- Advanced Technical Training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
- The ability to perform "hands on" troubleshooting and problem solving is required. The ability to think on the feet and providing sound judgment is high desired.
- Excellent technical understanding of manufacturing equipment and processes is required.
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
- Strong mentoring, coaching and leadership skills are required.
- Experience in supervising and directing the work of others is required.
- Advanced knowledge and proven leadership in the areas listed in the Duties and Responsibilities associated with the position.
- Demonstrated project management and project leadership abilities are required.
Johnson & Johnson Private Limited (8080)