PV QA/RA Supervisor

Job description

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. （一）质量体系管理（GB/ASME/PED）（GB/ASME/PED）Multi-standard Quality System Management (GB/ASME/PED) 1. 负责公司压力容器GB 国标体系、ASME 美标体系（U 钢印规范）、PED 欧盟承压设备指令体系的建立、落地、维护与持续改进，确保三大体系独立合规、兼容运行，贴合最新法规、标准及行业规范要求。 Responsible for the establishment, implementation, maintenance and continuous improvement of the company’s GB standard system, ASME standard system (U-Stamp specification) and PED EU Pressure Equipment Directive system for pressure vessels, ensuring independent compliance and compatible operation of the three systems in line with the latest laws, regulations, standards and industry specifications. 2. 主导压力容器质量手册、程序文件、作业指导书、检验规范、记录表单等体系文件的编制、修订、审核、发布与培训，统筹体系文件适配国内外不同项目标准要求。2. Lead the compilation, revision, review, release and training of system documents including pressure vessel quality manuals, procedure documents, work instructions, inspection specifications and record forms, and coordinate the adaptation of system documents to the standard requirements of different domestic and overseas projects. 3. 牵头组织体系内审、过程审核、产品专项审核、年度管理评审，跟进不符合项整改闭环，保障 ISO9001、压力容器制造许可、ASME 钢印、PED 认证资质持续有效。 Take the lead in organizing system internal audits, process audits, special product audits and annual management reviews, follow up the rectification and closure of non-conforming items, and ensure the continuous validity of ISO9001, pressure vessel manufacturing license, ASME U-Stamp and PED certification qualifications. 4. 指导、监督直属下属体系质量工程师开展日常体系运维、文件管控、内审筹备、体系培训、日常合规自查等工作，统筹分配工作任务，审核工作成果，解决体系运行疑难问题。 Guide and supervise subordinate system quality engineers in daily system operation and maintenance, document management, internal audit preparation and daily compliance self-inspection, allocate work tasks, review work results, and solve difficult problems in system operation. （二）压力容器产品 QA 质量管控 Pressure Vessel Product QA Quality Control 1. 审核压力容器项目质量策划、工艺质量方案、焊接工艺评定（WPS/PQR）、材料追溯方案、无损检测方案，确保所有生产活动符合对应标准规范。 Review pressure vessel project quality planning, process quality schemes, Welding Procedure Specifications/Welding Procedure Qualifications (WPS/PQR), material traceability schemes and non-destructive testing schemes to ensure all production activities comply with corresponding standard specifications. 2. 主导生产过程质量关键点、停工待检点（H 点）的质量管控，监督制程质量执行，及时识别制程质量隐患，组织预防管控，降低返工、报废质量成本。 Lead the quality control of key production process nodes and Hold Points (H Points), supervise the implementation of process quality, identify potential process quality hazards in a timely manner, organize preventive control, and reduce quality costs caused by rework and scrap. 3. 统筹产品质量记录、制造数据档案（MDR）的审核、归集、归档管理，确保 GB 产品出厂资料、ASME 出厂数据包、PED 符合性技术文件完整、真实、合规、可追溯。 Coordinate the review, collection and archiving of product quality records and Manufacturer’s Data Reports (MDR), ensuring the completeness, authenticity, compliance and traceability of GB product factory documents, ASME factory data packages and PED conformity technical documents. （三）PED/ASME 合规授权与认证管理（RA 核心职责） PED/ASME Compliance Authorization & Certification Management (Core RA Responsibilities) 1. 作为公司 ASME、PED 产品合规负责人，全权负责出口压力容器产品PED 合规评估、模块认证、CE 符合性声明编制审核，对接欧盟 NB 公告机构，完成年度审核、产品认证、合规备案工作。 Act as the company’s compliance person in charge for ASME and PED products, fully responsible for the compilation and review of PED compliance assessment, module certification and CE Declaration of Conformity for exported pressure vessels, dock with EU Notified Bodies, and complete annual audits, product certification and compliance filing. 2. 负责 ASME 钢印资质维护、年度审核、AI 授权检验对接，统筹 ASME 产品不符合项（NCR）管控、整改验证、关闭确认，保障 ASME 产品合规出厂。 Responsible for the maintenance of ASME U-Stamp qualifications, annual audits and docking with ASME Authorized Inspectors (AI), coordinate the management, rectification verification and closure confirmation of ASME product Non-Conformance Reports (NCR), and ensure the compliant delivery of ASME products. 3. 跟踪国内外压力容器法规、标准更新，同步更新公司体系及管控要求，确保新产品、在制产品、存量资质持续满足 GB、ASME、PED 最新合规要求。 Track updates of domestic and foreign pressure vessel laws, regulations and standards, synchronously update the company’s system and control requirements, and ensure that new products, in-production products and existing qualifications continuously meet the latest compliance requirements of GB, ASME and PED standards 4. 负责产品质量不合格、客户质量异议、第三方审核问题的原因分析、整改方案制定、闭环验证，建立质量合规案例库，形成长效管控机制。 Conduct cause analysis, formulate rectification plans and verify closure for product quality non-conformities, customer quality objections and third-party audit problems, establish a quality compliance case library, and form a long-term effective control mechanism. （四）对内团队管理与体系赋能 Internal Team Management & System Empowerment 1. 负责直属下属体系质量工程师的日常管理、工作考核、技能培训、能力提升，搭建稳定的质量体系团队。 Responsible for the daily management, performance appraisal, skill training and capacity improvement of subordinate system quality engineers, and build a stable quality system operation and maintenance team 2. 统筹内部质量体系宣贯、标准培训、案例培训，提升生产、技术、采购、检验等全员的 GB/ASME/PED 合规意识与实操能力。 Organize internal quality system promotion, standard training and case training to improve the GB/ASME/PED compliance awareness and practical capabilities of employees in production, technology, procurement, inspection and other departments 3. 对接生产、技术、采购等部门，协调解决项目生产、物料管控、检验交付中的体系及质量合规问题，推进各部门严格执行质量体系要求。 Dock with production, technology, procurement, sales and other departments, coordinate and solve system and quality compliance problems in project production, material control, inspection and delivery, and promote all departments to strictly implement quality system requirements. （五）对外跨境沟通与客户对接 Cross-border Communication & Customer Docking 1. 作为集团海外业务质量对接窗口，常态化对接集团国外分公司，同步国内外项目质量标准、合规要求、审核规则，传递总部质量管控规范，接收海外项目特殊质量要求，统筹内外质量标准统一落地。 Serve as the quality docking window for the group’s overseas business, regularly communicate with overseas branch companies of the group, synchronize quality standards, compliance requirements and audit rules for domestic and overseas projects, deliver headquarters quality control specifications, receive special quality requirements for overseas projects, and promote the unified implementation of internal and external quality standards. 2. 负责国外客户、海外分公司的质量问询、审核接待、质量异议沟通、项目质量进度同步，处理跨境质量对接问题，维护集团海外业务质量口碑。 Handle quality inquiries, audit receptions, quality objection communication and project quality progress synchronization for foreign customers and overseas branches, solve cross-border quality docking problems, and maintain the group’s overseas business quality reputation 3. 对接国内外第三方检验机构、认证机构、业主验厂审核，统筹审核筹备、现场配合、问题整改、报告闭环，保障各类审核、检验一次性通过。 Dock with domestic and foreign third-party inspection institutions, certification bodies and owner factory auditors, coordinate audit preparation, on-site cooperation, problem rectification and report closure to ensure one-time pass of all audits and inspections. （六）质量数据分析与持续改进 Quality Data Analysis & Continuous Improvement 1. 定期统计分析制程不良率、返工报废率、审核不符合项、客户投诉、海外项目质量问题等核心质量 KPI，输出质量分析报告。 Regularly collect and analyze core quality KPIs including process defect rate, rework and scrap rate, audit non-conforming items, customer complaints and overseas project quality problems, and issue quality analysis reports. 2. 主导质量持续改进项目，针对 GB/ASME/PED 产品共性质量问题、体系漏洞、合规风险，制定改进措施并落地落地，持续提升产品质量与体系成熟度。 Lead quality continuous improvement projects, formulate and implement improvement measures for common quality problems, system loopholes and compliance risks of GB/ASME/PED products, and continuously improve product quality and system maturity 工作经验： 1. 5 年及以上压力容器行业质量 QA/RA 管理经验，3 年以上独立负责 ASME、PED 出口压力容器合规管理工作经验。 At least 5 years of working experience in pressure vessel industry QA/RA quality management, with more than 3 years of independent experience in charge of ASME and PED exported pressure vessel compliance management. 2. 熟悉压力容器制造流程工艺，具备制造企业体系管理、第三方审核、海外项目对接经验者优先。 Familiar with the manufacturing process of pressure vessels; candidates with experience in system management, third-party audit and overseas project docking in large-scale formal manufacturing enterprises or state-owned enterprises are preferred 专业能力 Professional Competencies： 1. 精通核心标准：熟练掌握GB/T150 等国内压力容器标准，ASME Ⅷ 卷、U 钢印体系规范，欧盟 PED 2014/68/EU 指令及 CE 认证合规要求。 Proficient core standards: Master domestic pressure vessel standards such as GB/T150, ASME Volume Ⅷ and U-Stamp system specifications, EU PED 2014/68/EU Directive and CE certification compliance requirements. 2. 熟悉压力容器质量体系搭建、内审、管理评审、资质维护全流程，熟练处理 NCR 不符合项、AI/NB 审核问题整改闭环。 Familiar with the whole process of pressure vessel quality system establishment, internal audit, management review and qualification maintenance; proficient in handling NCR non-conforming items and closing rectification for AI/NB audits 3. 精通压力容器焊接、无损检测、热处理、压力试验等关键工序质量管控，熟悉 WPS/PQR 评定、材料追溯、出厂数据包编制审核。 Proficient in quality control of key processes such as pressure vessel welding, non-destructive testing, heat treatment and pressure test; familiar with WPS/PQR qualification, material traceability and compilation & review of factory data packages About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.