דרושים ב-Philips ב-Japan, Chiyoda

品質保証部マネジャ/ Quality Assurance Manager

【背景】/【Back Ground】

【サマリー】/【Job Summary】

Responsible for all aspects of quality assurance and quality management system (QMS) development, operation, and maintenance for medical devices, in collaboration with global HQ/ legal manufacturer and internal departments, based on medical devices sales, rental, and repair services in accordance with applicable laws, regulations, standards and company requirements.

【業務内容】/【Your roles and Key Areas of Responsibilities】

• 適用規制やISOの遵守事項を把握し、社内QMSへの適合を企画推進する
• 海外法人のQMSスタンダードへの適合プロジェクトを推進する
• 品質目標の管理を確実なものにし、QMSの適合性を評価し、マネジメントに報告する
• 文書管理・教育訓練管理をQMS全体で確実なものにする
• 業許可変更管理を確実に実行する
• 社内外との品質取決め書を維持管理する
• 内部及び外部品質監査への対応する
• 社内の品質マネジメントシステムへの移行及び展開に係る各種業務を行う
• 品質の確保、苦情処置、不適合品の管理、是正予防および改善、回収処理、製造販売業者への不具合等報告および連携を行う　等

• Understand requirements by applicable regulations and ISO standards, and plan and promote compliance with the internal QMS.
• Execute projects to ensure compliance with QMS standards by global HQ/legal manufacture.
• Ensure quality objectives, evaluate QMS compliance, and report to management/ stakeholders.
• Ensure document/record controls and training management throughout the QMS.
• Ensure the proper execution of regulatory licenses change management.
• Maintain and manage quality agreements with internal and external parties.
• Respond to internal and external quality audits.
• Engage projects/tasks related to the transition and implementation of the internal quality management system.
• Ensure quality assurance, complaint handling, manage nonconforming products, implement corrective and preventive actions, recalls, reporting defects to MAH (e.g. Philips Japan), and coordinate with them, etc.

【要件（必須）】/【Requirements (Mandatory)】

• 医療機器業界において5年以上の経験を有し、そのうち最低3年は品質部門での経験を有する方。
• 医薬品医療機器等法、ISO13485及び他関連する規制要件の知識を有する方。
• 医療機器の品質マネジメントシステムのプロセスの構築と運用の経験を有する方。
• 語学力： 日本語及び英語力（海外法人とコミュニケーション可能なビジネスレベル）

• > 5 years of experience in the medical devices industry, of which with a minimum of 3 years within quality field such as QA/QMS.
• Knowledge of the PMD Act, ISO 13485, and other applicable regulatory requirements.
• Experience in establishing and operating quality management systems for medical devices
• Language: Japanese (Native level), English (Business Level)

【尚可】/【Requirements (Preferred)】

• AED/除細動器やその他の救急医療製品について十分な理解を示している方。
• 医療機器ライセンスの取得とその後の維持管理の経験を有する方。
• 事業拡大の進捗に応じて、品質部門の最適な組織体制を設計管理できる方。

• A thorough understanding of AEDs, defibrillators and other emergency care medical devices
• Experience in obtaining medical devices licenses for a newly established legal entity and maintaining it thereafter.
• Ability to design and manage the optimal organizational structure for the quality department in accordance with business expansion progress.

Market Procurement Manager

Job Role:

• You will have the opportunity to contribute to the Philips Offering for Medical Equipment, Service and Software to our customers in Japan. Supporting the sales and services organization while making the connection with the Business Units through Business Partners, you will ensure Compliance/Quality, Cost and Delivery for all 3rd Parties Products & Services (such as Image Chain, OEM Systems, Medical Devices, Service Rental…), in addition to the Philips’ own systems and devices in the deal package. This may include stand-alone hospital offer, regional multi-modality deals up, to large government projects at the country level.

Key Responsibilities:

• You are responsible for 40 M€ spend through about 40 suppliers.
• Single Contributor Position locally. Focus given on diversity in large.
• Representing and positioning Procurement, interacting with key internal stakeholders, including Business Marketing Leader, Supplier Quality, Supply Chain & Legal team.
• Further defining the Procurement value proposal, balancing a project base approach into a Category and Project angle - promoting our standard catalog items.
• Ensuring 100% compliance through our own team according to local regulation, our Quality Management System, new Master Agreement, Cybersecurity directives and internal Policy.
• As part of continuous improvement, to propose and/or implement key process changes within your team and facilitate with other stakeholders.
• Implementing, with the Market Procurement Leader, the procurement strategy, country specific.
• Boosting and maintaining the short and mid-term productivity funnel, focusing on P&L impact, leveraging Year Over Year productivity (e.g. supplier consolidation, redesign to cost approach, strong negotiations practices….).
• Maximizing assurance of supply to safeguard our revenue and customer satisfaction.
• Managing the supply base (segmentation, consolidation, risk management, performance monitoring).
• You are a part of the Integrated Supply Chain and Procurement organization. As such, you will report into the Market Procurement Leader – International Markets.

You are part of The Integrated Supply Chain and Procurement organization, reporting to the Market Procurement Leader – International Markets.

You're the right fit if:

• A Bachelor’s degree, complemented with a last degree in Business, Supply chain or Procurement is preferred.
• A minimum of 5 years’ experience in Direct Procurement / Supply Chain/ Project Management within a Global matrix Medtech environment is needed as well.
• General know-how in Medical Devices or 3rd Parties ~ Brand-Labelling equipment, associated service (Installation, repair, ….) ; and overall regulation are real plus.
• Experience in sales/marketing/ project management is a plus. A first successful people management experience is appreciated as well – preference given in a multi-cultural context.
• Training / Certification in Lean or changing the acceleration process would help.
• Business acumen and constant inclusiveness, working hand with the Business Units, Market and Q&R management representatives.
• She/he will combine a “customer first” view together with no compromise on compliance.
• She/he will have influencing skills to challenge in a constructive way, legacy and status quo.
• Japan and English (750~) must have.

【休暇】初年度有給休暇　最大20日間（2年度～5年度 20日／6年度以降 25日 付与）、CareLeave（年間10日間）、Sick Leave（年間最大30日間）ほか

【研修制度】 各種オンライン研修、入社後のサポート研修あり

【その他】PhiliFlexポイント：72,000 ポイント（1ポイント＝1円）

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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Your role:

• The Philips Sonicare, Philips Zoom and Oral Healthcare portfolio link to Dental Professionals within an assigned geographic territory.
• Achieving established revenue growth expectations for dental practices within assigned territory
• Selling the Philips Oral Healthcare product portfolio to dental professionals to dispense or use with patients.
• Full understanding of the science and clinical significance behind the Sonicare power toothbrush, Zoom Whitening and Oral Healthcare products.
• Responsible for direct business-to-business selling and professional product detailing.
• Primary responsibilities include driving professional product usage, brand recommendations (MOR, Most Often Recommended), and meeting/exceeding direct sales targets.

You're the right fit if:

• You have a Bachelor’s Degree in Business Administration, Marketing, Sales or equivalent, required
• Your skills include exceptional written, verbal, phone, and presentation skills with the ability to quickly learn new concepts, and is proficient in CRM Systems, MS Office (PowerPoint, Excel, Word, Outlook).
• Business to Business, Dental or Medical Outside/Territory Sales experience is a plus but not required.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• Overnight travel approximately 15-30%

How we work together

This is a field role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about .
• Discover
• Learn more about
• Learn more about

plus company fleet/car. Total compensation may be higher or lower dependent upon individual performance.

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US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

be provided for this position.For this position, you must reside inwithin commuting distance to Irvine, CA territory