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Sr. Quality Assurance Specialist (PACS/RIS)
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Job Description
- Req#: C7ysPBTlhgei
Employer Industry: Healthcare Technology
Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Ability to work remotely with a flexible work schedule to support international teams
- Engaging cross-functional collaboration with Engineering, Clinical, and Marketing teams
- Involvement in the development and mentoring of junior staff
- Chance to ensure compliance with FDA regulations and contribute to product quality improvements
What to Expect (Job Responsibilities):
- Collaborate with cross-functional teams to support product development within Product Lifecycle Management (PLM) and New Product Introduction (NPI) processes
- Act as the Quality lead for design changes to ensure compliance with applicable standards and guidances
- Manage product-specific Quality Management System processes, including CAPAs and complaint management
- Integrate products resulting from corporate and/or product acquisitions
- Collect and monitor quality metrics in support of Management Review
What is Required (Qualifications):
- Bachelor's degree in a relevant field or equivalent experience (e.g., Associate's degree with 5 years of experience)
- Minimum of 5-8 years of experience in a regulated industry, with preference for FDA and Software as a Medical Device experience
- Strong knowledge of FDA Quality System Regulations, including 21 CFR 11 and 21 CFR 820
- Excellent written and oral communication skills
- Participation in regulatory audits is a plus
How to Stand Out (Preferred Qualifications):
- 8-10 years of experience in a regulated industry is preferred
- Knowledge of EU Medical Device Regulation (MDR), ISO 13485, ISO 14971, and IEC 62304
- Understanding of pre- and post-market clinical studies, including 21 CFR 812, 21 CFR 50, and 21 CFR 56
#HealthcareTechnology #QualityAssurance #CareerOpportunity #RemoteWork #RegulatoryCompliance
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