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Compliance Specialist III
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Job Description
- Req#: R-517560
Employer Industry: Medical Technology
Why consider this job opportunity:
- Salary up to $168,200 annually
- Opportunity for career advancement and growth within the organization
- Supportive and collaborative work environment
- Chance to make a positive impact on healthcare quality and compliance
- Comprehensive benefits package promoting well-being and development
- Commitment to a culture that values diversity and inclusion
What to Expect (Job Responsibilities):
- Manage all post-market quality aspects of the CAPA process including initiation, investigation, and implementation
- Provide guidance on quality systems with an emphasis on process controls
- Report project and CAPA status to functional leaders regularly
- Coordinate with complaint handling sites to ensure consistency and efficiency in complaint records
- Identify areas for quality improvement and implement necessary action plans
What is Required (Qualifications):
- Bachelor's degree and a minimum of 3+ years in medical device complaint handling/post-market surveillance
- Experience in TrackWise, SAP, or Salesforce enterprise platforms is preferred
- Solid understanding of QA, Regulatory, and Quality Compliance in the medical device industry
- Knowledge of FDA regulations and international standards related to complaint handling
- Strong proficiency with MS Office tools and excellent written communication skills
How to Stand Out (Preferred Qualifications):
- Experience in infusion pumps or infusion therapy
- Proficiency in TrackWise Complaint and/or CAPA systems
- Familiarity with good documentation practices and meticulous attention to detail
- Ability to work both independently and collaboratively with minimal supervision
#MedicalTechnology #QualityAssurance #CareerOpportunity #CompetitivePay #RegulatoryCompliance
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