As a RS Client Manager(Assessor/Auditor), you'll be responsible for frequently travelling and having overnight stays across the Taiwan. You'll assess to ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites, write up comprehensive reports and present these to the client. You'll also have the opportunity for occasional international travel to the USA and Europe. You'll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation). Key responsibilities & accountabilities: Undertake management system assessments in accordance with BSI requirements. Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate. Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame. Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio. Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met. Plan/schedule workloads to make best use of own time and maximise revenue-earning activity. Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested. Maintain and develop assessment skills and technical and management system standards knowledge. Provide technical support to clients through business development, sales and customer service staff Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”.
待遇面議
(經常性薪資達 4 萬元或以上)
Candidate specifications: Bachelor degree or above with medical device industry related major or main professional qualification in a relevant subject and have a comprehensive knowledge of ISO 13485 and EU medical device regulation * Minimum 5 years quality management and technology management working experience in the fields of Medical devices with biological active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body; Active medical device or active implantable device. IVD devices manufactured using metal or plastic processing, IVD devices manufactured using non-metal mineral processing, (e.g. glass, ceramics, textiles, rubber, leather, paper) Commercial understanding of compliance industry, minimum 2 years quality system management Knowledge of business processes and application of quality management standards Good verbal and written communication skills and an eye for detail Be self motivated, flexible, and have excellent time management/planning skills Can work under pressure Willing to travel on business intensively An enthusiastic and committed team player Good public speaking and business development skill will be considered advantageous Taiwan local hire
● 獎金/禮品 1. 依據營運績效發放年終獎金 2. 三節禮金/禮品 3. 生日禮金 4. 年度旅遊補助 5. 結婚/生育/住院/喪葬津貼 ● 保險 1. 團保(員工保費由公司全額補助;員工眷屬可以優惠方案自費加保) 2. 全年海外急難醫療救助 ● 福利 1. 員工旅遊 2. 午茶點心 3. 員工專屬coffee corner 4. 辦公室提供舒適按摩椅 5. 補助新進人員體格檢查 6. 每年提供同仁一次健康檢查 7. 醫師諮詢預約服務,提供員工心理/醫療等專業諮詢 ● 彈性的上下班時間 AM 8:00~9:00 / PM 5:00~6:00,以利同仁兼顧家庭照顧 ● 優於勞基法的休假制度