长沙招聘

职位描述：

Job Description Summary:
1. Ensures the annual definition of the quality improvement plan (QIP) based on business needs and timely implementation.
2. Supports on-site/off-site supplier quality development including coordination /management of required internal/external resources.
3. Manages the early involvement of suppliers in new product development and product/component improvement. Leads quality system audits.
4. Coaches and manages the SQE team ensuring the competences and capabilities are in line with the business needs. Deploys and follows-up on the Supplier Quality Related KPI’s towards the supplier.
5. Ensures the assigned supply base meets the Philips sustainability requirements. Ensures the timely and correct GSRS data-input. Participates in the Supplier Selection process for the quality aspects.
6. Sets supplier quality aspects for new / improved products ensuring a.o. manufacturability aspects at suppliers (improve supplied quality).

Description:
· Independently Produces and completes Supplier Quality Engineering related activities and documentation.
· Completes Qualification of materials and components (including spare parts), development/ improvement of supplier processes for CtQ's, supplier process control plans; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met.
· Qualifies and sustains sub-processes of suppliers, including performing process validations for critical supplier processes impacting part quality.
· Ensures that the components/products at the supplier (including spare parts and services) are released according agreed specification and quality requirements (APQP / PPAP), and SQ audit results.
· Executes SCAR management, effective and timely closure
· and Review/risk assessment of QN's and their escalation to SCARs where needed.
· Independently works to deploy common approaches and working methods to drive ‘’One Philips’’ towards Supply Base in the assigned BG or Market.
· Works on issues of diverse scope where analysis of situation or data requires identification and 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.

REQUIREMENTS:
Education:
· Bachelor’s degree in an engineering or science discipline, or equivalent experience.
· Current certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer (CQE) and Certified Quality Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead
Experience and Background:
· >5 years of total industry experience with 4+ years of related experience in a medical device or regulated industry.
· Working knowledge of appropriate global medical device regulations, requirements and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
· Experience in root cause analysis, corrective and preventive action methods.
· Expertise/experience in problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA/ 5WHY etc.
· Good knowledge of production/quality development and control methods; CtQ definition, DfSS, SPC, APQP, FMEA, Control Plans, etc.)

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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。

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