Medical Device QMS Auditor
$98.1k/y-$123.86k/y
BSI2 days ago
Highlight
OnsiteFull-timeMid
Summary
BSI is seeking a Medical Device QMS Auditor to join their team in Frisco, TX. The role involves analyzing quality systems and assessing ISO 13485, CE Marking, and MDSAP schemes to ensure patient safety and support market access for medical device products.
About the Role
As a Medical Device QMS Auditor, you will be responsible for preparing assessment reports, delivering findings to clients, recommending certificate actions, maintaining account responsibility, leading assessment teams, providing accurate information to support services, coaching colleagues, and planning workloads effectively.
About You
Required:
- Associate's degree or higher in Engineering, Science or related degree.
- Minimum of 4 years experience in the medical device field, including at least 2 years of hands-on medical device design, manufacturing, testing, or clinical evaluation experience.
- Knowledge of business processes and application of quality management standards.
- Good verbal and written communication skills and attention to detail.
- Self-motivated, flexible, and excellent time management/planning skills.
- Ability to work under pressure and willingness to travel intensively.
Preferred:
- Good public speaking and business development skills.
Benefits
- Competitive salary ranging from $98.1k to $123.9k.
- Group-sponsored health and dental insurance.
- Short-term and long-term disability coverage.
- Company-matched 401k plan.
- Company paid life insurance.
- 11 paid holidays and 4 weeks paid time off.
BSI
We are a business improvement and standards company that partners with more than 77,500 clients globally across multiple industry sectors. BSI provides organizations with the confidence to grow by working with them to tackle society’s critical issues – from climate change to building trust in AI and everything in between - to accelerate progress towards a fair society and a sustainable world. For over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives. Today BSI engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments to deliver on its purpose by helping its clients fulfil theirs.
Frisco, TX