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部署・役職名 | Supplier Quality Assurance Manager |
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仕事内容 |
Job Description Summary Assure that the Quality systems at the suppliers (including contract manufacturers) and Company HealthTech meet relevant Purchasing Controls requirements; scope of activity includes all QMS relevant Purchasing Controls processes, systems, and procedures, as well as Q&R processes indirectly related to Purchasing Controls (e.g., CAPA, audit). Participate in the development and continuous improvement of suppliers’ Quality Assurance processes to ensure high quality and compliance. SQA is accountable and responsible for supplier audits, external inspections/ audits of Purchasing, and training. Job Description ・Leads KAR-related assignments within Markets. ・Applies Company Excellence practices to identify and solve major supplier quality issues where simple analysis of Supplier Quality data is required. ・Has a multi-disciplinary approach and knowledge basic Supplier Quality principles, theories and concepts; including ASL Management, Auditing, SCAR Coordination, Performance Monitoring, and Quality Transition Plans. ・Formulates the Supplier Quality solution based upon Supplier Quality feasibility studies. ・Leads projects in Supplier Quality, managing a small number of people. ・Applies company policies and procedures to resolve a variety of issues. ・Has working knowledge of company products and services. ・Frequently interacts with functional peer groups, demonstrating the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules. ・Lead teams, fostering collaboration to deliver tasks. ・Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors ・Exercises judgment within defined procedures and practices to determine appropriate action ・Builds productive internal/external working relationships ・Able to focus on the problem, identifying the impact on the value chain (customer, supplier, company) and affected stakeholders. ・Normally receives general instructions on routine work, and detailed instructions on new projects or assignments. ・Able to make decisions based on data and facts. |
応募資格 |
【必須(MUST)】 REQUIREMENTS• Medical Device Awareness ISO 13485 & FDA QSReg (21 CFR Part 820), ISO 19011, CMDR, MDD, jPMD • GDP - Good Documentation Practices • SCAR Ownership, Execution and Independent Review • Supplier Sustainability • Six Sigma Qualification – DFMEA, Value Stream Mapping, MSA • QMS Relevance and it application & implications • ASL Awareness • Lead Auditor Qualification • Quality Agreement and Change Notice agreements 【歓迎(WANT)】 Soft Skills• Negotiation • Effective listening and communicating skills • Facilitation Skills • Develop Global Skills • Effective Communication & Presentation Skills • Strategic Planning and Execution • Customer Focus/Service • Project Management |
アピールポイント | 外資系企業 女性管理職実績あり 従業員数1000人以上 年間休日120日以上 産休・育休取得実績あり |
受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
更新日 | 2024/04/18 |
求人番号 | 3463973 |
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