Jobs in Puebla, Mexico

Great that you're thinking about a career with BSI!

Auditor – Medical Devices (CCAA qualification)

Location – China (work from home)

Are you looking for a career where you can use your expertise to ensure patient safety?

Do you want variety and exposure to different medical device manufacturers and cultures?

Your next career could be as an auditor; or as we call them at BSI a Client Manager.

• 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.
• 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 related major or an equivalent professional qualification in a relevant subject
• A medical device professional with training and a working knowledge of ISO 13485 & EU Medical Device CE Marking, Medical Devices Risk Management – ISO 14971, GHTF Basis Knowledge, Process validation, PMS & Vigilance system
• Minimum 4 years working experience in the fields of medical device
• Sterilization experience and microbiologist is preferable.
• IVD background and experience is preferable
• CCAA qualification is preferable
• 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

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 recruitment team.