MQ240127

品管/品保/安規            

Responsibilities & Authorities:
1. Responsible for quality oversight and execution for medical devices during the product lifecycle and the associated Quality System.
2. Work on assigned projects as the QA representative to support the business to ensure the design control process, relevant activities, and design history files (DHF) are in co
3. Establishes and maintains the QMS, ensuring it is capable of consistently meeting US FDA, EU MDR/IVDR, ISO 13485, TW QMS, other applicable regulations and other customer requirements.
4. Serves as the Quality Management Representative for Local site for 3rd party and regulatory audits and oversees and excutes quality management review and quality audit processes and reports to Director of Division.
5. Develops and deploys the quality plan ensuring alignment with QMS, regulatory and customers' requirements.
6. Direct and manage Quality Team for quality oversight or execution of the quality assurance assurance in different sites and quality control activities in local site for all projdcts during the product lifecycle and the associated Quality System.
7. Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.
8. Manages the CAPA process and review board for ensuring all employees associated with CAPA action items have the capabilities and resources to complete their assignments.
9. Direct team member and manage processes for deviations, risk assessments and nonconforming material reports.
10. Handle and manage product RMA, complaint process, inquiry requests or investigations in accordance to client or regulator’s requirements.
11. Oversees and supervises the change control process and approval.
12. Responsible for the assigned projects as the QA representative to support the business to ensure the design control process, relevant activities, and design history files (DHF) are in compliance with internal QMS and regulatory requirements.
13. Engages with and influences the management team and other stakeholders such as product development, logistics and suppliers to maintain a focused quality culture within the facility.
14. Ensures the facility process validation system is executed appropriately and maintains compliance to medical device expectations and master validation plans.
15. For the assigned manufacturing sites, ensures finished product shipped from the facility conforms to the Finished Product Specification and Compliance of Certificate (CoC) for product release and is documented in a device history record. Has authority to hold non-conforming or potentially non-conforming product.
16. Ensures incoming materials meet raw material specifications with the authority to reject nonconforming raw materials. Communicates material issues and partners with suppliers to improve performance through the SCAR (Supplier Corrective Action Request) process as appropriate.
17. Ensures that processes are delivering on their intended outputs by selection and review of critical quality KPIs and run to target methodologies.

桃園/新竹/苗栗

面議

Must Have:
1. Degree in related field (engineering, science, biological, or related field).
2. Strong Quality and QMS background and experience in the Medical Device Manufacturing.
3. 5+ years industry experience in QA filed of Medical Device/Pharmaceutical industry. RA experienced may be considered 8+years industry experience in Medical Device/Pharmaceutical distribution.
4. Knowledge and experience of the regulatory and compliance requirements of FDA 21 CFR Part 820 QSR, ISO 13485, EU MDR, and ISO 14971.
5. Experience supporting cross functional teams and cross factory sites.
6. Traveling may be requested based on the projects.
7. Proficiency in English.

Nice To Have:
1. Quality related license/certificate, e.g. CQT, Lean Six Sigma.
2. Knowledge of 21 CFR CFR Part 4, MDR Art 117, and TW QMS.
3. Audit experience.
4. RD or RA experience.

醫療/生化

知名全球最大數位相機設計與製造大廠，於2008年投入醫療電子，屢獲國際醫療品牌大廠指定代工，持續發展微小化、低耗能、無線化等特性並結合數位影像技術應用，提供醫療影像解決方案，耕耘高端醫材有成。

享勞、健保、勞工退休金提撥 / 其它依勞動基準法、性別平等工作法、全民健康保險法等規定之相關福利