BSI · 1 month ago
QMS Auditor
United States
Full-time
Remote
Mid Level
$98K/yr - $124K/yr
4+ years expBSI is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. The QMS Auditor role involves analyzing quality systems, preparing assessment reports, and maintaining account responsibility to ensure effective partnerships and service delivery.
Business DevelopmentCollaborative ConsumptionRecruiting
Responsibilities
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
Qualification
Required
Associate's degree or higher in Engineering, Science 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
Preferred
Good public speaking and business development skill will be considered advantageous
Benefits
Group-sponsored health and dental
Short-term and long-term disability
A company-matched 401k plan
Company paid life insurance
11 paid holidays
4 weeks paid time off
Company
BSI
BSI Group, also known in its home market as the British Standards Institution, is a multinational business services
1001-5000 employees
H1B Sponsorship
BSI has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
2023 (3)
2022 (6)
2021 (3)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
B
Beverley Webb
Lead Programme Manager, Defence and Security
Egor Malychev
Sales Director DACH
Recent News
News Powered by Cision
2025-10-31
2025-10-28
Company data provided by crunchbase