Medical Devices QMS ISO 13485 Auditor

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Position: Medical devices QMS auditor

Location: South Korea(home based with business travelling)

*Please note that visa sponsorship is not available for this role. Only candidates with the legal right to work locally will be considered.

What duties you'll perform:

• As a RS Client Manager(Auditor) you'll be responsible for frequently travelling and having overnight stays across the South Korea. 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).

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.

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”.

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 .

• Native Korean speaking and if you have JLPT N1 is a plus.

• Experience in Active Medical Devices will be highly preferred ​.

• 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.

Key performance indicators:

• Delivery of man-days 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.

About Us

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.
 
Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.