Quality Systems II Specailist
$75,000–$110,000 year
On-site · Burnsville, Minnesota, United States
Job Summary
Quality Systems Specialist II responsible for supporting a compliant quality management system, including CAPA, nonconformance, internal/external audits, document and records management, change control, training, and quality metric analysis. Develops and maintains quality system procedures to ensure regulatory compliance, participates in audits, leads CAPA projects with timely records, investigates quality issues with root cause analysis, and provides cross-functional training and guidance on quality system requirements and best practices.
Required Qualifications
- Bachelor’s degree in a related technical field
- 3-5 years of experience in quality assurance or other quality systems roles in the medical device industry
- Previous CAPA and nonconformance experience and demonstrated use of quality tools and methodologies
- Detailed knowledge of 21 CFR Part 820, ISO 13485, EU MDR, and other global regulatory requirements
- Advanced computer skills, including statistical/data analysis and report writing skills
- Strong verbal and written communication skills
- Excellent attention to detail. Multitasks prioritize and meet deadlines promptly
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.