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Senior Quality Specialist - Remote - Invitae
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Job Description
- Req#: 2443580
Employer Industry: Healthcare Diagnostics
Why consider this job opportunity:
- Salary range up to $135,000 annually
- Comprehensive benefits package including Medical, Dental, Vision, Life, and 401(k)
- Opportunity for career advancement and growth within the organization
- Flexible work options with the possibility to work 100% remotely
- Supportive and collaborative work environment focused on quality improvement
- Chance to make a positive impact on client satisfaction and patient outcomes
What to Expect (Job Responsibilities):
- Administer the electronic Quality Management System (Jira) for documenting quality management activities
- Collaborate with team members and leaders to maintain and enhance system performance
- Train and mentor subject matter experts in quality program practices
- Serve as a subject matter expert for Quality Programs during external audits
- Monitor, analyze, and report Quality Program data at Site Management Review meetings
What is Required (Qualifications):
- Bachelor's degree in a relevant scientific discipline or engineering
- Minimum of 7 years of experience in Quality Assurance and/or Regulatory Affairs
- Experience in clinical diagnostic laboratory, medical device, or related industry
- Proven experience managing or leading quality management programs
- Strong technical capability in quality processes and program management
How to Stand Out (Preferred Qualifications):
- Knowledge and/or experience with regulatory requirements including CLIA, NYSDOH, and CAP
- Familiarity with FDA regulations and ISO standards (e.g., QSR 820, ISO 13485, ISO 15189)
- Yellow or Green Belt in Lean Six Sigma
#HealthcareDiagnostics #QualityAssurance #CareerOpportunity #RemoteWork #CompetitivePay
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