Job Description
To conduct various types of audits to work closely with BSI clients to help them improve their performance by assessing their systems and processes against BSI standards
- 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.
- Maintain overall account responsibility and accountability for nominated accounts to ensure an effective partnership, whilst ensuring excellent service delivery and account growth.
- 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.
- 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
- Plan/schedule workloads to make best use of own time and maximise revenue-earning activity.
Qualification:
- Bachelor's degree or above with a 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 4 years of quality management and technology management working experience in the fields of:
- Medical devices with biologically 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) .
- Certification Body background.
- 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
- 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.
