Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

About the job:

The role is responsible for ensuring timely and effective implementation of all company's policies and procedures as well as Taiwan's Good Distribution Practice (GDP) related activities. The role needs to work closely with the stakeholders and regional / division Quality Assurance (QA) team to support post-market activities and local Quality Management System (QMS) activities in meeting Corporate Standard Operating Procedures (SOP) and Taiwan's regulatory requirements.

What you will be doing:

• Support the stakeholders' SOP regular review / revise process.

• Make proactive recommendations and solutions to RAQA and other departments to improve quality, efficiency and also meet the regulatory and company requirements.

• Support to maintain QMS for Corporate requirements and Taiwan GDP requirements.

• Provide the regional QA with regular updates on quality KPI.

• Act as regional and local quality document controller.

• Participate in all regulatory, corporate, internal, external audits and inspections, and corrective action response.

• Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.

• Handle product complaint through internal system, adverse event reporting to local authority, product hold and product field action coordination.

• Collaborate with Taiwan RAQA and share quality knowledge and information to other departments.

• Act as a QA backup for Hong Kong's QA team member.

• Perform other duties as directed by RAQA manager.

Who are we looking for:

• At least bachelor's degree in healthcare, medical, engineering / related major is preferred but not limited to.

• Good knowledge in Taiwan MDGDP, Medical device Act and ISO 13485.

• Relevant rich quality experiences in healthcare industry.

• Minimum 8 years of experiences.

• Having Hong Kong's RAQA experience is plus.

• Strong team player and detailed oriented.

• Excellent communication skills with proficiency in spoken and written English & Chinese.

• High ethical standards and integrity.

• Well-organized and logical thinking.

• Good at planning, patient, and have a great sense of accountability.

• Ability to handle multiple tasks simultaneously.

NOTE: Please attach an English version of your CV when applying for this role.

關於工作：

該職位負責確保及時有效地實施公司的所有政策和程序以及台灣醫療器材優良運銷準則 (GDP) 相關活動。此角色需要與其他相關部門和區域/部門品質保證 (QA) 團隊密切合作，支援上市後活動和當地品質管理系統 (QMS) 活動，以滿足企業標準作業程序 (SOP) 和台灣的監管要求。

你將要做什麼：

• 支援相關部門的SOP 定期審查/修訂流程。

• 向RAQA 和其他部門提出積極的建議和解決方案，以提高品質、效率並滿足監管和公司要求。

• 支援維持品質管理系統以滿足企業要求和台灣GDP 要求。

• 向區域QA 提供品質KPI 的定期更新。

• 擔任區域和當地的品質文件控制員。

• 參與所有監管、公司、內部、外部審計和檢查以及糾正措施回應。

• 透過與其他部門合作，協助調查和糾正品質相關問題（包括客戶投訴）。

• 透過內部系統處理產品投訴、向地方當局報告不良事件、產品保留和產品現場行動協調。

• 與TW RAQA 合作並與其他部門分享品質知識和資訊。

• 作為香港QA 團隊成員的QA 後備。

• 履行RAQA 經理指示的其他職責。

我們在找誰：

• 至少擁有醫療保健、醫學、工程/相關專業學士學位，但不限於此。

• 熟悉台灣MDGDP、醫療器材管理法和ISO 13485。

• 醫療保健產業相關豐富的品質經驗。

• 至少8 年經驗。

• 擁有香港的RAQA 經驗者更佳。

• 團隊合作精神強，注重細節。

• 優秀的溝通能力，精通中英文口語和書面文字。

• 高道德標準和誠信。

• 良好的組織和邏輯思維。

• 善於計劃，有耐心，有較強的責任感。

• 能夠同時處理多項任務。

注意：申請此職位時，請附上英文版履歷。

About Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com. (http:)

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.