Home Based Auditor – Medical Devices

13485 HOME BASED AUDITOR – MEDICAL DEVICES – FRANCE

Job Type:

Permanent

Location:

Home/Field Based France (ANYWHERE)

Start Date:

ASAP

Duration:

To be determined

Salary:

45-65,000

Bonus: 10%

Training: Yes (Full)

Title: Lead Auditor/Client Manager Medical Devices
Reports to: Assistant VP
Industry: Medical Device – Manufacturing/Production
Location: Home/Field based FRANCE – Nationwide
Experience: Min experience: 4 years medical devices graduate
Overview:
Responsible for delivering audit services to assigned clients in accordance with all scheme and regulatory requirements to assure timely, cost effective service delivery that assures satisfaction of our customer needs.
The ideal candidate must be familiar with CE Marking and have 4 years of "hands on" medical device manufacturing or production experience.
Background would include experience with manufacturing of metals, rubber and plastics, as well as electrotech/electronics.
Essential Responsibilities:
Analyze quality systems and assess ISO 13485 and CE Marking.
Responsible for attending any required training and following all procedures/processes/policies within BSI for management of clients, management of a home based office, use of equipment and communication both internal and external to the organization.
Responsible for following the training plan developed by the AVP in order to reach assessor status and then Lead assessor.
Participate in additional training based on future business needs.
Responsible for managing a portfolio of assigned clients based on location and a match of qualifications and client contract requirements.
Responsible for contacting clients and scheduling the visits, planning the assessments, making travel plans, conducting the assessments and reporting and managing the results.
Responsible for monitoring the client accounts to ensure that records, PointGlobal information, visit cycle, invoicing and other related matters are properly dealt with to assure client satisfaction is maintained.
Responsible for leading teams, when necessary, and mentoring and coaching new or inexperienced colleagues as needed to meet the business needs.
Any other assignments as needed to meet assessment delivery business objectives.
Education/Qualifications:
College degree AA or higher (or equivalent certification or work experience)
Knowledge:
Generic knowledge of management system auditing practices
Knowledge of general office practices, information systems, documentation systems, and technology including computers.
Knowledge of the specific products and processes and organizational structure of the client.
Knowledge of the outcomes of prior audit activities of the client.
Knowledge of competences of the audit team members for the client.
Travel:
This position requires travel to and from clients. This includes both land (car) and air travel.
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