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Quality & Regulatory Specialist II (Hybrid)
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Job Description
- Req#: R11661
Employer Industry: Healthcare Quality and Regulatory Compliance
Why Consider this Job Opportunity:
- Opportunity for career advancement and growth within the organization
- Hybrid work model offering flexibility between in-office and remote work
- Engaging workplace culture where every associate feels valued and supported
- Chance to make a positive impact on patient safety and quality of care
- Involvement in diverse projects within the medical device regulatory landscape
What to Expect (Job Responsibilities):
- Conduct research and provide guidance on medical device QMS and regulatory standards
- Manage and maintain the Quality and Regulatory Compliance Program, including audits and CAPA processes
- Provide support and education to Field Operations teams regarding quality and regulatory compliance
- Monitor and assess Field Operations site performance to ensure compliance with established standards
- Lead efforts in quality improvement and support reverse and new implementations
What is Required (Qualifications):
- Minimum of 2 years of experience in clinical engineering, healthcare quality, compliance, or medical device industry
- Bachelor's degree or equivalent experience in a related healthcare field, applied science, QMS, or clinical engineering
- Basic working knowledge of quality management systems and risk management
- Strong written, verbal, and presentational communication skills
- Proven analytical and problem-solving skills to diagnose and resolve issues
How to Stand Out (Preferred Qualifications):
- ISO 13485, 9001, and/or 27001 internal audit experience
- Basic to intermediate Excel skills for data reporting and analysis
- Experience with interpreting clinical engineering and healthcare regulations
- Ability to participate in multiple projects in a team environment
- Strong organization and time management skills
#HealthcareQuality #RegulatoryCompliance #CareerGrowth #HybridWork #PatientSafety
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