莆田招聘

职位描述：
Position Summary
? Manages all Quality Assurance activities associated with the product development and product support processes in Asia Pacific. Ensures that all quality-related systems for R&D are established and documented to provide a safe and effective product that meets customer needs. Responsible for the internal audit program. Establishes and administers Quality Assurance/Quality Systems policies and procedures which will enable R&D to respond rapidly to customer needs. Provides leadership, quality oversight and direction, scheduling, decision-making, problem-solving and team-building capabilities. Maintains and expands QA/QS and supervisory knowledge in areas applicable to Quality Engineering.

Key Responsibilities
? General Function
o Manage Quality Engineering staff and guide the Quality Engineering function in Greater China to support product development.
o As a Deputy Quality Management Representative, support the quality management system. Ensure compliance to FDA QSR, ISO9001 and ISO 13485 quality system and participate in Management Review meetings.
o Specific focus on the design control requirements of the regulations.
o Responsible for quality function output in the product development process within Greater China.
o Responsible for Situational Analyses and Risk Management Reports for products designed by Greater China R&D.
? Quality System/ Product Development:
o Product development process: Lead design control compliance within the phase gate product development process as specified for the business. Lead evolution and improvement of the product development process.
o Ensure quality and accuracy of integrated project plans encompassing all cross-functional activities. Perform periodic reviews of progress against plans. Ensure plans are executed appropriately within department. Be accountable for timely delivery of all product development deliverables as specified in the plans.
o Review, provide input, and approve QS systems documents to ensure compliance with QSR, ISO, and EN requirements. Track and report system changes.
o Drive continuous improvement of the Quality System. Perpetually benchmark BD Quality System and processes against those of best-in-class external organizations, propose improvements and train the organization in best practices.
o Provide periodic status reports containing quality system and product quality information. Report on significant findings requiring immediate action by the organization on a timely basis.
o Responsible to attend design reviews for product development projects.
? Organizational Management
o Accountability: Demonstrate strong and clear accountability for the group’s performance and delivery. Accountable for ensuring application of quality engineering to product development from concept to market launch to meet business objectives. Utilize statistical techniques as applicable to Design and Development activities.
o Participation and communication: Participate in the Business Unit/Region R&D leadership team. Inform other WW Quality groups of activities, projects, capabilities, and direction of the group. Seek and provide synergies, collaboration opportunities, and support in common objectives.
o Budgeting: Develop detailed budgets in accordance with project and organization plans, and business objectives. Manage budget diligently and be accountable to perform to the budget.
o Resourcing: Align dedicated and shared resources cross-functionally to optimize and ensure success of new product development.
o Technology transfer: Organize and communicate to ensure efficient and effective transition from research to development to manufacturing.
o Metrics: Define actionable metrics to measure Quality Engineering performance against business objectives, monitor periodically and frequently to identify gaps quickly, and mitigate early.
o Process effectiveness: Ensure appropriate processes are followed for effective and timely engagement of other parts of the company in product development activities.
o Innovation: Develop and apply innovative approaches to ensure best outcomes in all aspects of the role. Create an environment in which innovation can flourish through empowerment, encouragement, and support.
? Organizational Development
o Associate development: Actively develop and mentor associates. Provide frequent feedback.
o Actively recruit best talent and design long-term career paths and development to attract and retain.
? Ensure proper assembly and maintenance of the Design History File (DHF).
? Follow BD’s Global Product Development System (GPDS).
? Travel as required by project scope and timing.
? Select, develop, organize, motivate, and coordinate staff to effectively fulfill their functions. Manage the HR pipeline, building the necessary skills to execute the Quality Engineering plan and provide for effective leadership succession.
? Ensure compliance with BD local regional, international quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles.
Education
? Minimum
o Bachelor’s degree in mechanical engineering or related discipline.
? Desired
o Master’s degree in business or related engineering discipline.

Other Qualifications - Professional Certification
? Minimum
o Not applicable.
? Desired
o Certified Quality Engineer, Certified Quality Manager, Certified Quality Auditor, and/ or Six Sigma Green/Black Belt.

Experience
? Minimum
o 12 years relevant experience in design quality, quality record documentation, quality system requirements, GMP compliance, quality auditing, and CAPA systems, including 3 years’ experience supervising technical/ quality professionals.
o Successful track record of delivering quality products to market, preferably in the instrumentation and/ or medical device industry.
o Experience in project planning, management, and leadership.
o Experience in a Phase-Gate development process.
o Experience working with multi-disciplinary teams.
o Experience running multiple projects directly while managing other quality assurance resources running separate projects.
o Experience leading internal and external compliance audits.
o Experience administrating CAPA program.
o Prior experience assembling, maintaining, and auditing Design History Files DHFs.
o Practical and demonstrated experience of Quality or Reliability engineering/QA/QS, risk analysis, product development, and verification/validation testing.
? Desired
o Product design experience in the medical device industry.
o Experience in the design and development of quality products in accordance with ISO 13485 guidelines.

Required Knowledge and Skills
o Advanced knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.) is an advantage
o Advanced knowledge and understanding of quality engineering principles and concepts, total quality tools, continual improvement approaches, industry practices, and standards.
o Advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements.
o Advanced leadership, motivational, and team building skills, with the ability to lead organizational change.
o Advanced interpersonal skills with the ability to manage, motivate, and influence both up and down the organization.
o Advanced technical and managerial judgment and demonstrated decision-making capabilities.
o Advanced understanding of approaches to work breakdown, prioritization, resource allocation, and problem solving.
o Excellent verbal and written communication skills.
o Business acumen and ability to develop business cases and justifications.
o Entrepreneurial drive and demonstrated ability to achieve stretch goals in an innovative and fast paced environment.
? Desired
? Knowledge of engineering performance enhancement tools in the area of Design for Six Sigma (such as Voice of the Customer, Statistics, Design of Experiments, and Problem Solving). 举报 分享

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit ******.

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BD是一家全球化的医疗技术公司，通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD关注并支持每位一线医务工作者，致力于通过研发创新技术、服务和解决方案，帮助患者改善临床治疗，并帮助医护人员改进临床流程。BD及其65,000名全球员工秉承高度的热情和信念，致力于帮助提升患者的治疗效果，为临床医护人员提供安全、高效的护理给药流程，协助实验室科学家们更有效地诊断疾病，并提升科研人员研发新一代诊断及治疗疾病的能力。BD在几乎所有国家均设有分支机构，与全球范围内的组织机构积极合作，携手应对最具挑战的全球健康问题。通过与客户的紧密协作，BD以改善治疗结果，降低医疗成本，提升诊断效率为己任，帮助加强患者和医护人员的安全并扩大医疗可及性。2017年，BD欢迎巴德及其产品加入BD大家庭。更多信息，敬请访问**********/china。