Medical Device Assessor/auditor(Home Based)

1 week ago

Kuala Lumpur, Kuala Lumpur, Malaysia BSI Full time
Great that you're thinking about a career with BSI

About BSI and the Regulatory Services Team:

  • BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.
  • 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.

What duties you'll perform:

  • As a RS Client Manager, you'll be responsible for frequently travelling and having overnight stays across the Malaysia. 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, reissue 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 revenueearning 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".
  • 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 nonmetal mineral processing, (e.g. glass, ceramics, têxtiles, rubber, leather, paper)
  • Commercial understanding of compliance industry, minimum 2 years quality system management
  • 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
  • Malaysia local hire.

Key performance indicators:

  • Delivery of mandays as booked in time and good quality work together with positive feedback from clients
  • Feedback efficiently to both clients and internal queries
  • Timely submission of reports
  • Actively solve problems when needed with "can do" attitude
  • Add value to clients by identifying their needs and introducing multiple BSI services to improve clients business performance and help them "Make excellence a habit"
  • Help to avoid customer attrition by providing quality value added service and technical support

Our Excellence Behaviours:
Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our

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