SCOPE OF THE ROLE AND BASIC PURPOSE
§ Medical Devices & Diagnostics Global Services, LLC., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D Supply Chain supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
§ The Site Quality Leader 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. Site Quality Leader will act as a mentor to more junior staff and advice top management on technical matters.
§ The Site Quality Leader 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.
KEY RESPONSIBILITIES/TASKS (indicate estimated % of time spent where possible)
1. 50% - Quality
2. 40% - Site/JJKK
3. 10% - Other global plants / Other company (i.e. ASP)
§ Lead or support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
§ Lead or support quality aspects for site-level projects: divestiture, internal product transfer, service and repairs
§ Is responsible for product incoming inspection, and proper and timely disposition of defective products
§ Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
§ Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the 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.
§ As a representative of quality in make site, conduct periodic line audits to assess adequacy of production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
Product Quality, Control & Disposition and Performance Standards
§ Lead and maintain Material Review Board.
§ Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.
§ Escalate and coordinate the quality issues and actions with global franchise and manufacturing sites 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.
§ 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.
Production/Process Controls including Control Plans
§ 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.
§ Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes.
§ Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
§ 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.
§ Strategically promote collaboration with HQ from License maintenance & management
§ Establish and maintain department/cost center budget.
§ Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning.
§ Be a strong advocate for Quality & Culture at Sukagawa as a Senior Site Quality Leader.
§ This job is based in Sukagawa site and expect minimal travels may require up to 5% travel
Position Management Dimention
§ Number og Employee to supervise :15
Education & Training:
Nice to Have/
Post Graduate Technical Degree
Training (Quality, Regulatory)
Engineering (QE, 滅菌、など)
Excellent English Speaker/Writer
Fluent Oral/Written English
No. of Years
Nice to Have
Under 2 years
2 – 4 years
4 – 7 years
7 – 10 years
10 – 15 years
15 + years
Required Competencies and Skills
§ A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field. Generally, requires 5-8 years related experience including 2-4 years specific experience in a management/supervisory role.
§ Experience working in both an FDA and European regulatory environment is preferred.
§ This position will require relevant experience working in manufacturing/operations.
§ Advanced Technical Training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
§ Excellent technical understanding of manufacturing equipment and processes is required.
§ 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 K.K. (8235)