Medical Devices QMS ISO 13485 Auditor
BSI
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇰🇷 South Korea
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Responsible for assessing ISO 13485 quality management systems, EU medical device regulations, and MDSAP scheme on customer sites
- Write comprehensive reports and present to clients
- Undertake management system assessments in accordance with BSI requirements
- Prepare assessment reports and deliver findings to clients
- Recommend the issue, re-issue or withdrawal of certificates
- Lead assessment teams ensuring effective working relationships with clients and team members
- Develop client partnerships to enhance business opportunities
- Provide accurate and prompt information to support services
- Plan/schedule workloads to maximize revenue-earning activity
- Coach colleagues and assist in their induction
Requirements
- Bachelor degree or above with medical device industry related major or main professional qualification in a relevant subject
- Minimum 5 years quality management and technology management working experience in the fields of Medical devices
- Native Korean speaking, JLPT N1 is a plus
- Commercial understanding of compliance industry, minimum 2 years quality system management
- 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
Benefits
- Comprehensive training
- Opportunities for international travel
- Supportive work environment
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
ISO 13485quality management systemsEU medical device regulationsMDSAPquality system managementbusiness processesreport writingassessment reportingcoachingtime management
Soft skills
communication skillsteam leadershiprelationship buildingself-motivationflexibilityattention to detailplanning skillsability to work under pressureenthusiasmcommitment