About the Role
BSI is seeking a qualified ISO 13485 Quality Assurance Auditor. The individual will be responsible for delivering BSI’s audit services to assigned clients in accordance with all BSI, scheme and regulatory requirements to assure timely, cost effective service delivery that assures satisfaction of our customer needs. The ideal candidate must have knowledge of CMDCAS and CE MARK and have 2 years of “hands on” medical device manufacturing experience. Background would include experience with the design, development & manufacturing of metals, rubber and plastics, organics, IVD as well as electrotech/electronics (or a combination thereof).
- 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 BSI 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.
This great opportunity for an ambitious professional to gain visibility within the organization.
We seek someone who meets all of the following criteria:
- Can deliver and strive for superior performance, and who can achieve challenging objectives
- Are proactive with people and can lead by example
- Can demonstrate passion for the business and can inspire others
- Have integrity, ensuring that business is conducted in an ethical manner
- Have commercial focus, understanding customers’ needs and adding value
- College degree AA or higher (or equivalent certification or work experience)
- This position requires a minimum of 100% travel to and from clients. This includes both land (car) and air travel.
- A minimum of four years of full-time hands-on work experience in the field of medical devices or related sectors (e.g. medical industry, healthcare, audit or research), including at least two years in the area of quality management. Full time hands-on direct work experience can be in one or more of the following:
- Research and development, manufacturing, service;
- the application of the device technology and its use in health care services and with patients;
- testing the devices concerned for compliance with relevant national or international standards;
- conducting performance testing, evaluation studies or clinical trials of the devices.
- A minimum of degree level qualifications relevant to medical devices and your hands-on work experience (electrical, mechanical or bioengineering / biology or microbiology / chemistry or biochemistry / computer and software technology / human physiology / medicine / pharmacy / physics or biophysics)
- In exceptional cases, a shorter duration of experience, or experience in areas not mentioned above, or education other than a degree, may be acceptable. Such cases may include, for example, individuals employed in an audit, inspectional or enforcement position for a regulatory authority whereby they have acquired and demonstrated in-depth knowledge of medical device design and manufacturing, as well as the evaluation of compliance of medical device manufacturers to standards and regulations. Such cases shall be considered on an individual basis and shall be justified and documented.