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Job Description:

Job Summary:

• Provides leadership and oversight for Product Quality, Supplier Quality Management, Purchasing Controls, Manufacturing Quality (incl. Product Release), and Quality System activities within J&J Med Tech Neurovascular China and the assigned supplier quality scope.
• This role ensures products, suppliers, subcontractors, processes, and services comply with applicable Johnson & Johnson requirements, regulatory expectations, and industry standards. The position drives supplier performance, quality risk management, audit readiness, continuous improvement, and effective Quality System execution while communicating significant quality risks and opportunities to management.

Key Duties and responsibilities:
Under limited supervision and in accordance with applicable laws, regulations, Johnson & Johnson procedures, and guidelines, this position:

• Oversee Supplier Quality Management, Purchasing Controls, Manufacturing Quality, Product Release, and Quality System activities within the assigned scope.
• Develops and maintains risk-based supplier quality strategies, including supplier selection, qualification, monitoring, performance management, and supplier corrective actions.
• Provides oversight of suppliers, subcontractors, and external service providers to ensure compliance with approved agreements, procedures, training, and quality requirements.
• Reviews and approves manufacturing and sterilization records and authorizes product release, as assigned.
• Leads or supports corrective and preventive action, nonconformance management, supplier corrective action, calibration, validation, audit readiness, and other assigned Quality System processes.
• Analyzes quality and supplier performance data to identify trends, risks, and improvement opportunities and provides recommendations to leadership and Management Review.
• Leads and supports internal audits, supplier audits, regulatory inspections, notified body audits, and related readiness, response, and follow-up activities.
• Collaborates with Procurement, Manufacturing, Engineering, Research and Development, Regulatory Affairs, Supply Chain, Commercial, Quality Compliance, and other functions to improve products, processes, suppliers, and Quality Systems.
• Reviews and approves quality documentation, including Supplier Quality Agreements, procedures, work instructions, validation documents, inspection reports, and related records.
• Provides leadership, coaching, mentoring, and technical guidance to quality personnel and cross-functional partners.
• Communicates significant quality risks, issues, opportunities, and business impacts to management in a timely manner.
• Ensures compliance with Company Health, Safety, Environmental, regulatory, and quality requirements.
• Performs other duties as assigned.

Experience and Knowledge:

• Bachelor's degree in Engineering, Science, Life Science, or a related technical field is required.
• Minimum 7 years of medical device industry experience is preferred, including responsibility for quality management system processes or subprocesses.
• Experience in supplier quality, purchasing controls, manufacturing quality, quality systems, or regulatory compliance is required.
• Experience supporting regulatory inspections, audits, corrective and preventive action, nonconformance management, validation, production controls, or sterilization controls is preferred.
• People management, talent development, coaching, or technical leadership experience is preferred.
• Proficiency with Microsoft Word, Excel, and PowerPoint is required.
• Fluent English and strong written and verbal communication skills are required.

Skill Sets and/or Training and/or Certification for the Special Position

特殊岗位的技能和/或培训和/或证书要求

• Working knowledge of applicable medical device quality system and regulatory requirements, including 21 CFR Part 820, ISO 13485, China GMP for implantable and sterile medical devices, ISO 14971 or risk management principles, European Union medical device requirements, and Medical Device Single Audit Program jurisdictions, as applicable.
• Strong understanding of supplier quality management, purchasing controls, manufacturing quality, corrective and preventive action, nonconformance management, supplier corrective action, validation, and audit readiness.
• Strong analytical, problem-solving, judgment, decision-making, and communication skills.
• Ability to analyze quality data, assess risk, recommend actions, and verify effectiveness.
• Ability to collaborate and influence in a matrixed, cross-functional environment.
• Ability to work independently, lead complex initiatives, and develop team capabilities.
• Knowledge of medical device manufacturing, sterilization, microbiology, statistical methods, Lean, and Six Sigma is preferred.
• Knowledge and experience in key manufacturing and quality processes to build implantable medical devices, especially extrusion, PIM(Plastic Injection Molding), assembly, packaging in clean room, sterilization processes, as well as key infrastructure set up, validation and maintenance to support implantable medical device manufacturing (clean room, RO/DI water, compressed air, etc.)
• American Society for Quality, Six Sigma, Lean, Project Management Professional, or equivalent certification is preferred.

Required Skills:

Preferred Skills: