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Director Bsi Lead Auditor Jobs (NOW HIRING)

BSI Group

... BSI? * Top-rate pay, benefits and work life balance * Funded certification as an eIDAS Lead Auditor and ISO/IEC 27001 Lead Auditor * Long-term career development within an emerging digital trust ...

BSI Prof Serv EHS West

... BSI? * Top-rate pay, benefits and work life balance * Funded certification as an eIDAS Lead Auditor and ISO/IEC 27001 Lead Auditor * Long-term career development within an emerging digital trust ...

BSI Group

EHS Auditor / Consultant

Miami, FL · Remote

$102K - $127K/yr

BSI Consulting Services is seeking a seasoned Environmental, Health, and Safety Auditor to join our ... Plan, lead, and execute EHS and environmental compliance audits at client facilities across the U.S ...

BSI Group

EHS Auditor / Consultant

Knoxville, TN · Remote

$102K - $127K/yr

BSI Consulting Services is seeking a seasoned Environmental, Health, and Safety Auditor to join our ... Plan, lead, and execute EHS and environmental compliance audits at client facilities across the U.S ...

BSI Group

EHS Auditor / Consultant

Tampa, FL · Remote

$102K - $127K/yr

BSI Consulting Services is seeking a seasoned Environmental, Health, and Safety Auditor to join our ... Plan, lead, and execute EHS and environmental compliance audits at client facilities across the U.S ...

BSI Group

EHS Auditor / Consultant

New Orleans, LA · Remote

$102K - $127K/yr

BSI Consulting Services is seeking a seasoned Environmental, Health, and Safety Auditor to join our ... Plan, lead, and execute EHS and environmental compliance audits at client facilities across the U.S ...

BSI Group

EHS Auditor / Consultant

Atlanta, GA · Remote

$102K - $127K/yr

BSI Consulting Services is seeking a seasoned Environmental, Health, and Safety Auditor to join our ... Plan, lead, and execute EHS and environmental compliance audits at client facilities across the U.S ...

BSI Group

EHS Auditor / Consultant

Jacksonville, FL · Remote

$102K - $127K/yr

BSI Consulting Services is seeking a seasoned Environmental, Health, and Safety Auditor to join our ... Plan, lead, and execute EHS and environmental compliance audits at client facilities across the U.S ...

BSI Group

EHS Auditor / Consultant

Memphis, TN · Remote

$102K - $127K/yr

BSI Consulting Services is seeking a seasoned Environmental, Health, and Safety Auditor to join our ... Plan, lead, and execute EHS and environmental compliance audits at client facilities across the U.S ...

BSI Group

EHS Auditor / Consultant

Concord, NC · Remote

$102K - $127K/yr

BSI Consulting Services is seeking a seasoned Environmental, Health, and Safety Auditor to join our ... Plan, lead, and execute EHS and environmental compliance audits at client facilities across the U.S ...

BSI Group

EHS Auditor / Consultant

Nashville, TN · Remote

$102K - $127K/yr

BSI Consulting Services is seeking a seasoned Environmental, Health, and Safety Auditor to join our ... Plan, lead, and execute EHS and environmental compliance audits at client facilities across the U.S ...

BSI Group

EHS Auditor / Consultant

Saint Louis, MO · Remote

$102K - $127K/yr

BSI Consulting Services is seeking a seasoned Environmental, Health, and Safety Auditor to join our ... Plan, lead, and execute EHS and environmental compliance audits at client facilities across the U.S ...

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Director Bsi Lead Auditor information

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$32.5K

$102.9K

$147K

How much do director bsi lead auditor jobs pay per year?

As of Aug 23, 2026, the average yearly pay for director bsi lead auditor in the United States is $102,886.00, according to ZipRecruiter salary data. Most workers in this role earn between $80,500.00 and $132,500.00 per year, depending on experience, location, and employer.

What is the difference between Director Bsi Lead Auditor vs Bsi Lead Auditor?

AspectDirector Bsi Lead AuditorBsi Lead Auditor
CertificationsISO 9001, ISO 14001, ISO 45001 Lead Auditor certificationsISO 9001, ISO 14001, ISO 45001 Lead Auditor certifications
Work EnvironmentOversees multiple audits, manages teams, strategic planningConducts audits, assesses compliance, reports findings
Employer & IndustryTypically in large organizations or consulting firmsIn various industries, including manufacturing, services, and certification bodies

The main difference is that the Director Bsi Lead Auditor often has managerial responsibilities and oversees audit programs, while the Bsi Lead Auditor primarily conducts audits and assesses compliance. Both roles require similar certifications and work environments, but the director position involves strategic oversight and team management.

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Director Bsi Lead Auditor jobs near you
Infographic showing various Director Bsi Lead Auditor job openings in the United States as of August 2026, with employment types broken down into 67% Full Time, and 33% Part Time. Highlights an 67% In-person, and 33% Remote job distribution, with an average salary of $102,886 per year, or $49.5 per hour.

Quality Analyst/EU Auditor

Siri InfoSolutions Inc

Austin, TX • On-site

Contractor

Re-posted 7 days ago

Job description

Job Title : European Union Medical Device Regulation Auditor

Location: Austin, TX

Duration: 6 months

Key Responsibilities:

  • Plan, scope, and lead comprehensive mock audits to assess readiness for an upcoming BSI notified body audit.
  • Evaluate the medical device manufacturer’s Quality Management System (QMS) against ISO 13485:2016 and the EU MDR 2017/745.
  • Conduct rigorous onsite or virtual stress-testing of core QMS processes:
  • Management Responsibility & Resource Management
  • Design and Development / Technical Documentation Files
  • Production and Service Provision (Cleanroom, Sterilization, Validation)
  • CAPA, Complaint Handling, and Post-Market Surveillance (PMS)
  • Review Technical Files and Design History Files (DHF) to ensure alignment with BSI expectations.
  • Prepare detailed mock audit reports, classifying findings into Major and Minor nonconformances using Notified Body criteria.
  • Provide a definitive gap analysis report outlining critical vulnerabilities and immediate remediation strategies.
  • Debrief leadership and process owners on audit outcomes, providing actionable guidance on how to interface with BSI auditors.
  • Assess the readiness of subject matter experts (SMEs) through simulated front-room/back-room interview dynamics.

Required Qualifications:

  • Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
  • Minimum 8 years of experience in the Medical Device industry, specifically in Quality Assurance or Regulatory Affairs.
  • Certified ISO 13485 Lead Auditor (IRCA, Exemplar Global, or equivalent).
  • Proven track record of preparing medical device manufacturers for successful Notified Body audits, specifically with BSI.
  • Deep, current knowledge of ISO 13485:2016, ISO 14971 (Risk Management), and European medical device regulations.
  • Strong analytical, interviewing, and technical report-writing skills.
  • Ability to deliver objective, critical feedback constructively under tight preparation timelines.

Preferred Qualifications:

  • Former BSI Lead Auditor experience is highly preferred.
  • Hands-on experience managing a front-room/back-room during a live BSI QMS audit.
  • Experience auditing the specific device risk classification and technology relevant to our product portfolio.
  • Familiarity with MDSAP requirements.

Key Competencies:

  • BSI Audit Readiness & Notified Body Interface
  • Rigorous Gap Analysis & Nonconformance Classification
  • Risk-Based Auditing & Technical File Evaluation
  • SME Coaching & Interview Preparation
  • Objective, High-Pressure Stakeholder Communication
Siri Infosolutions logo

About Siri Infosolutions

Sourced by ZipRecruiter

Our team of experts first gather each and every requirement of yours. Our research and development team then sit around those requirements and come up with a plan. Our implementation team then executes that plan for optimal results. After that our support team remains in constant touch with you during and after the entire process.

Industry

It services

Company size

201 - 500 Employees

Headquarters location

Edison, NJ, US

Year founded

2005

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