长沙招聘

In this role, you have the opportunity to

• Be in the Zhuhai factory Operations PQMS organization to support the transformation activities of Factory.
• A major focus of this position will be working within a global network to address and Quality System improvements, training initiatives, Software Controls applicable to the US, Canada and EU related to non-product software systems

            

    

You are responsible for

    

• Define and maintain the Quality Management System procedures to ensure compliance to Philips Policies, ISO 9001, ISO 13485, 21 CFR 803, 806 and 820, Canadian Food, Drugs, and Medical Devices Regulations (CMDR) and EU Medical Device Regulations.

        

·         Maintain, enforce, and manage a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels.

• Manage PQMS/PEPF related deployments and implementations.
• Ensure all mandatory training requirements are set and training is executed as required.
• Administer both profiles and training records in line with regulatory requirements.
• In close cooperation with supervisors and QMS management, administer profiles for all jobs with respect to job effectiveness / qualification, as well as QMS / Regulated Training Management.
• Ensure Training Management System set-up.
• Control and administer all trainings assigned to users in compliance with the applicable requirements.
• Ensure the addition and management of any local QMS documents in line with the evolution of the PQMS Trainings.
• Ensure training and training registration as per the QMS and generates training content for local QMS documents as necessary.
• Define and establishes a lean practice (tools, methods, standards, competency, process and process performance) for SW validation & lifecycle control of new and existing SW systems.
• Executes and /or manages SW validation & control activities.
• Ensures the accuracy, completeness and compliance of SW validation deliverables by reviewing the SW validation packages of SW applications, which automate Quality System processes.
• Author, reviews and/or approves SW validation deliverables for non-product SW, including but not limited to SW validation plans, requirements, test plans/protocols/results, risk assessments, traceability matrix and summary reports.
• Work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
• Follows processes and operational policies in selecting methods and techniques for obtaining solutions.

                                                            

    

You are a part of:

• Philips Quality and Regulatory Team, it has recently restructured its organization to ensure you and your department have clear collaborates with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.

        

To succeed in this role, you should have the following skills and experience

• Bachelor’s degree in a scientific or technical field
• 2+ years of experience in Quality system management or Engineering/production functions with process validation (non-product software system) related knowledge or experience, experience in medical device industry preferred.
• Working knowledge of GMP’s and other FDA regulations, Experience in FDA Remediation projects-preferred
• Experience validating application activities.
• Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.
• Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
• Strong IT skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications.
• Proven analytical capabilities
• Excellent communication, organizational and project management skills
• Successful experience working with cross functional teams across multiple work locations
• Effective written and oral communications skills and computer skills required
• Network oriented and able to interact with different business functions and can work within numerous systems
• Work cooperatively in a team environment

荷兰皇家飞利浦公司是一家领先的健康科技公司，致力于在从健康生活方式、疾病预防、到诊断、治疗和家庭护理的整个“健康关护全程”，凭借先进的技术、丰富的临床经验和深刻的消费者洞察，不断推出整合的创新解决方案，助力健康医疗系统实现四重目标——提高大众健康水平、提高医护人员满意度、改善患者体验，并降低关护成本。飞利浦的愿景是通过有意义的创新，令世界更健康、更可持续的发展，到2030年每年改善25亿人的生活。

        飞利浦公司总部位于荷兰，2021年销售额达172亿欧元，在全球拥有大约78,000名员工，销售和服务遍布世界100多个国家。公司目前在诊断影像、图像引导治疗、病人监护、医疗信息化以及消费者健康和家庭护理领域处于领导地位。

        在飞利浦，每一个人，都至关重要。这是我们始终坚持的信念。在飞利浦，你将用数字化驱动有意义的创新，积极影响自己与数十亿人的生活，践行改善人类生活的使命。我们全心营造多元包容的工作环境，平等互助的工作氛围，让你的独特之处得到充分尊重和欣赏，鼓励你释放真我，以梦为马，不负韶华。本着 “立足中国，辐射全球” 的理念，我们通过布局广泛的业务线，为你带来广阔的平台、丰富的学习资源、多样的内部发展机会，助你成为具备全球化视野和本土深度的一专多能复合型稀缺人才。

创美好，做真我，迎蜕变。
我们深信每一个你都卓尔不凡, 更期待与志同道合的你笃行致远。