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BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.
Our Medical Devices (or Regulatory Services) team ensures patient safety while supporting timely market access for our clients' medical device products globally. BSI is an accredited ISO 13485 Certification Body recognized in many global markets.
This role is to act as a ISO/13845 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 candidate must be located in Massachusetts and willing to travel at a 60% of the time.
Analyze quality systems and assess ISO 13485, CE Marking and MDSAP schemes.
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 maximize revenue-earning activity.
Bachelor’s degree or higher in electrical, mechanical or bioengineering or related degree required
Minimum of 4 years experience in the medical device field including at least 2 years must be hands-on medical device design, manufacturing, testing or clinical evaluation experience.
The candidate will develop familiarity with BSI systems and processes as they go through the qualification process.
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.
BSI is an Equal Opportunity Employer and we are committed to diversity
BSI is your business improvement partner. We have shaped best practice for over 100 years, helping organizations around the world embed excellence, build competence and capability for sustainable growth.