Medical Device QMS & BSI Audit Readiness Lead

VOLTO Consulting; Austin (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

VOLTO Consulting is looking for a qualified candidate to oversee BSI readiness audits in Austin, Texas. You will be responsible for planning, scoping, and leading mock audits for a variety of medical device manufacturers, ensuring compliance with ISO 13485:2016 and EU MDR 2017/745.

The ideal applicant should possess a Bachelor's degree in a relevant field and at least 8 years of experience in Quality Assurance or Regulatory Affairs. Strong analytical skills and the ability to provide constructive feedback are a must.

Qualifications

• Minimum 8 years of experience in the Medical Device industry.
• Certified ISO 13485 Lead Auditor (IRCA, Exemplar Global, or equivalent).
• Deep knowledge of ISO 13485:2016 and EU medical device regulations.

Responsibilities

• Plan and lead mock audits for BSI notified body.
• Evaluate QMS against ISO standards.
• Prepare detailed mock audit reports.

Skills

Analytical skills

Interviewing skills

Technical report writing

Objective feedback delivery

Education

Bachelor’s degree in Engineering, Life Sciences or related field

Job description

VOLTO Consulting is looking for a qualified candidate to oversee BSI readiness audits in Austin, Texas. You will be responsible for planning, scoping, and leading mock audits for a variety of medical device manufacturers, ensuring compliance with ISO 13485:2016 and EU MDR 2017/745.

The ideal applicant should possess a Bachelor's degree in a relevant field and at least 8 years of experience in Quality Assurance or Regulatory Affairs. Strong analytical skills and the ability to provide constructive feedback are a must.