Executive Director, Design Assurance

品質保証・薬事

職務内容／Job duties	【PURPOSE/SUMMARY】 The role will develop and oversee the following processes in support of the Global Design Assurance team: ・Oversight over the global risk management process, including global harmonization and effective training tools to deploy to cross-functional collaborating team members ・In collaboration with the CTO organization, develop, deploy and educate staff on compliant and globally harmonized design control processes ・Establish consistency in the application of statistics throughout the design control processes and adjacent processes as it relates to effective engineering principals as well as design verification and validation ・Management of governance and operating mechanisms focused on driving product Quality and Compliance objectives. ・Oversight of Quality Data and actions to implement improvements across the Olympus product portfolio. ・In collaboration with Olympus Quality Systems and Compliance organizations, develop and implement compliance strategy designed to lower regulatory burden and compliance risk for ESD organization. The role works closely with other functions and strategic partners such as R&D, Manufacturing, Medical Safety, and Regulatory Affairs to establish, drive, and achieve excellence in product development initiatives, as well as leading cross-functional failure analysis teams to quickly and effectively identify root causes for escalated issues. The role will design and build a strong and data driven organization equipped with world-class competencies to enable and deliver on Olympus business, Quality and Compliance objectives. This includes internal teams located across the Americas, EMEA, Japan and APAC as well as third-party support teams located off-shore. 【PRIMARY DUTIES AND RESPONSIBILITIES】 The role will focus on building and developing the following key competencies and processes: ・Six Sigma black belt a plus. ・Expected to understand strategic priorities developed by executive management and to respond to requests with appropriate urgency and with an organized approach. ・Ability to operate independently and highly autonomously, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines. Provides solutions to highly complex, and significant issues; develops solutions based on in-depth technical knowledge, company policies, or defined process paths. ・Knowledge of national and international regulations applicable to medical devices including but limited to; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC ・Ability to analyze and interpret all regulatory and quality guidelines needed ・Demonstrate a strong “business partner” approach and attitude providing creative and innovative solutions that meet quality standards ・Thinks “Out of the Box” to optimize Quality goals and business value. ・Ensures that improvement objectives are based on strong analytical foundation and established a structure, foundation and governance for transparent and actionable quality and compliance data. ・Works across functions to establish improvement programs focused on improving Quality, Compliance and Customer satisfaction. ・Provides inspection and audit support to various Olympus sites. ・Proactively identifies and alerts organization of quality issues/complaints in time to resolve potential adverse effects to the customer, company image/reputation and/or the business. ・Develops and maintains Design Quality Data Scorecard to ensure transparency across the portfolio. Builds governance and process to ensure actions are taken across the organization based on adverse trends. ・Works closely with Compliance and RA organization to identify and act on regulatory trends requiring changes to QMS, products or processes. ・Build and implement a strategy to improve Quality Mindset and Quality Culture throughout the organization. ・Develop, build and maintain a strong Six Sigma / Lean organization focused on implementing continuous improvement programs to support product development teams. ・Mentors, manages, and develops direct reports. 【SUPERVISOR RESPONSIBILITIES】・10-15 associates with 6 - 8 direct (Directors, Sr. Manager, Principal Engineers, Data Scientist) reports ・Manages, coaches, and develops a high performing team that meets agreed objectives, and which delivers best practice results, added value and continuous improvements. ・Sets / delivers to global objectives/KPIs and reviews and assesses ongoing performance of direct reports as well as ‘dotted line’ reports in other regions (as may be required). （変更の範囲 / Scope of change）会社の定める業務 Business as defined by the company 【採用人数】 1名
応募資格／Qualifications	【必須要件】 ◆Education◆ Bachelor’s degree or equivalent in a Life Science focus, Engineering, or Physical Science required with an advanced technical degree and MBA preferred. ◆Experience◆ ・Minimum of 15 to 20 years of experience in quality management or design assurance with at least 5-7 years of management experience in a global position in a regulated environment in the MedTech industry. ・Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry such as: ISO, QSR, GMP, GLP, GCP, HIPAA. ・Demonstrated expertise in the design, implementation and measurement of quality systems and metrics. ・Initiative in innovative approaches to quality and compliance in a fast-paced changing business environment. ・Excellent written and oral communication and organizational, project management skills. ・Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence. ・"Out of box" strategic thinker with strong leadership ability. ・As a change agent, motivated to improve organization and not be satisfied with status quo. ・Experienced in initiating, cultivating and embedding a cultural change in a complex and diverse Olympus organization. ◆Skills◆ ・Excellent interpersonal and leadership skills with diverse cultural approach. ・A self-starter motivated and able to positively motivate others. Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside Olympus. ・Focused, target driven with a positive, can-do attitude and a desire to improve patient experience as well as company performance. ・Excellent writing and verbal skills 【選考フロー】 ※本ポジションは選考にあたり英文レジュメのご提出が必須となります。日本語の履歴書・職務経歴書と併せて、ご提出をお願いいたします。書類選考→面接：3回～4回（ポジションに応じて増える可能性があります） ※面接は基本webでの実施です
待遇／Salary & Benefits	【雇用形態】正社員（試用期間3ヶ月：待遇の変更はなし）【勤務時間】 8：45～17：30 （休憩：昼45分）　標準労働時間8時間 ※フレックスタイム制度あり（管理職採用の場合対象外）　コアタイム11：15～13：30 ※時短勤務制度あり ※テレワーク勤務あり【休暇・休日】・休日　　：土日祝、年末年始、GW、夏期休暇・年間休日：129日（自社カレンダーに応ず）・有給休暇：20日間の年次有給休暇を付与。 ※入社初年度は入社月にて変動します（最大20日） ※時間単位での取得も可能です（一部条件有）・育産休暇：取得実績あり（2022年度育児休暇取得率：女性94％※1、男性70.2％）・特別休暇：結婚、出産、忌引き、転勤　など・私傷病特別休暇・治療との両立に伴う特別休暇（厚労省が支援を推奨する疾病に対して、特別休暇を付与）・リフレッシュプラン ※対象年度の出産者の育児休業取得率は100％であるが、出産者の産後休暇が期間内に含まれるため94％となっています。【想定年収・手当】 1200万～2000万 ※想定年収については、目安です。ご経験やスキルに応じて当社の処遇基準にて決定いたします。手当：交通費支給、次世代手当（管理職採用の場合対象外）、在宅勤務手当など【保険】社会保険完備（雇用保険、健康保険、厚生年金、介護保険、労災保険）【福利厚生】※1 退職金制度：確定給付企業年金、確定拠出年金育児サポート：企業内託児所、出産祝い金、ベビーシッター補助※2 その他：従業員持株会、財形貯蓄、カフェテリアプラン※3、社内食堂、社外シェアオフィス、健康診断※4、団体保険 ※1）記載の福利厚生については各種規定、条件がございます ※2）内閣府企業主導型ベビーシッター利用支援事業 ※3）自己啓発、健康増進、育児・介護支援など様々なメニューから選択して利用できます ※4）35歳以上の方は健康診断で内視鏡検査を受診する場合は全額補助が出ます
勤務地／Location	（雇入れ直後 / Immediately after hiring） ■グローバル本社（東京都八王子市石川町2951）働く場所は在宅・新宿サテライトオフィス・宇津木事業所・シェアオフィス（社外）なども可能です。活用方法や頻度は部署と職種により異なります。詳細は面接時にご確認願います。新宿サテライトオフィス（東京都新宿区西新宿2-3-1 新宿モノリス）雇用契約はグローバル本社にて締結します。【受動喫煙対策】事業場内禁煙（変更の範囲 / Scope of change）会社の定める場所(テレワークを行う場所を含む) Workplace determined by the company(including the location where the telework will take place)