職務内容/Job duties
【オリンパスについて】
1950年に世界で初めて胃カメラの実用化に成功してから、医療従事者と共に内視鏡医療の発展に貢献してきました。
世界をリードするメドテックカンパニーとして、私たちは医療従事者の方々と共に、病変の早期発⾒、診断、そして低侵襲治療に役立つ最適なソリューション・サービスの提供を通じて対象疾患における医療⽔準の向上に貢献してまいります。
オリンパスは「私たちの存在意義」として掲げる、世界の人々の健康と安心、心の豊かさの実現を目指しています。
5つのコアバリュー「Patient Focus(患者さん第一)」「Integrity(誠実)」「Innovation(イノベーション)」「Impact(実行実現)」「Empathy(共感)」は、私たちが患者さんの安全や品質を最優先するグローバル・メドテックカンパニーとして成長していくための指針です。

【Team Overview】

The QARA (Quality Assurance and Regulatory Affairs) division at Olympus plays a critical role in ensuring the safety and quality of medical devices while adhering to regulations in various countries.

The team is involved throughout the entire product lifecycle, from development to post-market activities, collaborating with other departments to support the delivery of high-quality and highly reliable products

Additionally, the division contributes to compliance in global markets and the formulation of quality and regulatory strategies, aiming to deliver products that earn the trust of healthcare professionals and patients alike.

By joining the QARA team, you will have the opportunity to engage in socially significant work that supports the future of healthcare.

【Role Overview】 (Immediately after hiring)

Provide Quality Engineering support to ensure compliance with the Quality System regulatory requirements and the business strategy of the company.

Represent's Quality as a team member to support new product development procurement manufacturing returns and servicing of products produced.

【Key Responsibilities】

• Cross-Functional Team member to support new product development procurement manufacturing and servicing processes representing Quality Engineering discip

line.· Completes assigned Quality Engineering tasks to sche
dule.· Promotes awareness of Quality and Regulatory requirem
ents.· Leads or participates in the development of process and procedure development/cha
nges.· Applies statistical process co
ntrol· (SPC)methods to evaluate current processes and process cha
nges.· Develops new approaches to solve problems identified as part of the team. Assist in the implementation of compliance and maintenance of standards (e.g. FDAISO13485) and OGA Quality policies and proced
ures.· Applies the requirements of the Quality System to processes, products or services for the loca
tion.· Provides support to metrology and preventive maintenance prog
rams.· Supports validation and verification strategy for new and existing products and processes as assi
gned.· Leads the development and maintenance of Master Validation
Plan.· Participates in the CAPA process as required as an assignee or project team me
mber.· Investigates escalated product complaints to root cause to ensure timely customer response and correc
tion.· Authors collaborates and approves Quality System documentation including change orders DHF DMR DHR labels and labelling
etc.
Develops and drives measurable Quality improvements relating to products processes and services. All other essential related duties as required

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【Qualifications】

Education*:

• Bachelor's degree in Engineering discipline or equivalent.
• Knowledge of basic mechanical, electric, software, optical, or biological engin

eering.· Knowledge of basic medical device regulations and standards (e.g. 21CFR part 820, ISO 13485, ISO
14971).· Proven experience working with design controls (e.g. design input, design output, design verification, design validation, design transfer, traceability, design review, design change, design history file
, etc.)· Working knowledge of risk management (execution, tools, structure, and applic
ation).· Working knowledge of test method validation practices and tec
hniques· Working knowledge of problem-solving skills – good statistical and analytical
skills.· Working knowledge of problem-Solving Tools (i.e. Process Mapping Histograms FMEA Risk Assessment Cause & Effect Diagrams PDCA Pareto Analysi
s etc.)· Working knowledge of Quality Tools (i.e. Quality Planning Quality Costs and Assessment Basic Statistics Advance Statistical Techniques Technical Writing Metrology & Calibration Inspection and Testing Sampling Principles
and AQLTOM Lean Six Sigm
a etc.)· Good verbal and written communication skills demonstrated by ability to generate technical reports and ability to make presentations to middle and upper management Proven Project Management skills. Proficient in the use of Information Technology and applic
ations.· Leadership experience to lead and manage cross-functional

teams.· English ability:
TOEIC 800 plus or equivalent.

【歓迎(WANT)】
[Leadership Competencies]

• Customer focus: Building strong customer relationships and delivering customer-centric s

olutions.· Decision quality:
Making good and timely decisions that keep the organization moving

forward.· Strategic mindset:
Seeing ahead to future possibilities and translating them into breakthrough st

rategies.· Action oriented:
Taking on new opportunities and tough challenges with a sense of urgency, high energy, and en

thusiasm.· Ensures accountability:
Holding self and others accountable to meet com
mitments.· Demonstrates self-awareness: Using a combination of feedback and reflection to gain productive insight into personal strengths and we

aknesses.· Situational adaptability:
Adapting approach and demeanour in real time to match the shifting demands of different si

tuations.· Develops talent:
Developing people to meet both their career goals and the organization
's goals.· Drives engagement:
Creating a climate where people are motivated to do their best to help the organization achieve its ob
jectives.· Manages complexity - Making sense of complex, high quantity, and sometimes contradictory information to effectively solve
problems.· Managing Execution - Providing direction, delegating, and removing obstacles to get w
ork done.· Influencing People - Maneuvering comfortably through complex policy, process, and people-related organizational.

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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)







***※本職種の採用はオリンパスメディカルシステムズ株式会社へ在籍
出向扱いとなります。ただし、勤務地や給与、福利厚生はオリンパス

株式会社と同様です。(原籍会社:
オリンパス(株)/出向会社:オリンパスメディカルシステムズ)







***【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/コアタイム無し(管理職採用の場合対象外)※時短勤務制度あり※テレワーク
勤務あり・時間外労働あり
〈ご参考〉業務の状況等により変更となる可能性がございます

【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。

【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

(雇入れ直後 / Immediately after hiring)
■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)
■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。
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)
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