Medical Device Electrical Engineer (QA Auditor)
About the Role
BSI is seeking technically competent people with a background in electrical engineering who can be trained to become a qualified ISO 13485 Quality Assurance Auditor (Client Manager). 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:
- 4 years of medical device industry experience in total at minimum
- 2 years of “hands on” manufacturing design, testing or clinical experience
- Background could include experience with the design, development & manufacturing with metals, rubber and plastics, or coatings or surface treatments
It would be an advantage if the candidate possessed:
- Knowledge of 21.CFR820, CMDCAS and CE MARK registration processes
- MDSAP certification scheme
- Using technical experience and knowledge of regulatory environment to assess manufacturer’s quality systems to ISO 13485, CMDCAS, MDSAP and CE Marking requirements.
- Following all procedures/processes/policies within BSI for management of clients.
- Primarily responsible for managing a portfolio of assigned clients based on location and a match of qualifications and client contract requirements.
- Delivery of well-written auditreports to clients in a timely manner.
- Responsible for monitoring the client accounts to ensure that records, information, visit cycle, invoicing and other related matters are properly dealt with to assure client satisfaction is maintained.
- As a successful candidate is developed, they will become responsible for contacting clients and scheduling the visits, planning the assessments, making travel plans, conducting the assessments and reporting and managing the results.
- The successful candidate will develop towards 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.
The role is home-based. The role entails travel across the United States and occasional travel abroad. Every effort is made to make travel regional although travel is a core requirement of this position. Travel can be physically demanding.
BSI conducts training to ensure thorough knowledge of regulatory processes and standards that are relevant. The successful candidate brings industry and technical knowledge to the role.
We seek someone who meets all of the following criteria:
- Strive for and consistently deliver superior performance while achieving challenging objectives
- Are proactive with people and can lead by example
- Can demonstrate passion for quality and can inspire clients
- Have integrity, ensuring that our 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)
- Make decisions based on objective evidence
- Strength of character to stand by decisions that affect patient safety or quality outcomes
- Detail focused to understand client management systems
- View things from practical point of view to see big picture
- Can work independently with minimal supervision
- Construct and communicate complex arguments
- Ability to write effective and clear reports
- 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, design and development, manufacturing, service;
- application of device technology and its use in health care services and with patients;
- testing 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 (electro-mechanical engineering / bioengineering / biology or microbiology / human physiology / 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.