Medical Devices Auditor(microbiology微生物專業背景者優先)-home based

Purpose of Position:

As a RS Client Manager, 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 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).

About BSI and the Regulatory Services Team:

Our Regulatory Services team ensure patient safety while supporting timely market access for our clients Medical Device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands, is an accredited ISO 13485 Certification Body and is recognized in many global markets.

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

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：

Hands-on experience of working as a microbiologist in the manufacture of sterile products.

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;

Thorough knowledge of Medical Device regulation.

Concepts and intent of product certification and service delivery.

Knowledge of business processes and the application of quality management standards.

Conceptual and analytical thinking, efficiency and focus on results .

Broad technical understanding of clients, medical device industry and sterile products.

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.

Willing to travel on business intensively.

Taiwan local hire.