Quality System Integration Specialist - Contractor

Employer Industry: Medical Device Manufacturing

Why consider this job opportunity:
• Salary up to $50 per hour
• Comprehensive benefits package including medical, dental, and vision coverage
• 401k matching and employee stock purchase plan (ESPP)
• Opportunities for career advancement and professional development
• Supportive work environment with a focus on wellness and diversity
• Flexible vacation time and recognition awards

What to Expect (Job Responsibilities):
• Integrate and maintain Quality Systems in compliance with FDA regulations and ISO standards
• Create, revise, and review Quality System documents to ensure regulatory compliance
• Support the migration of documents and records into electronic systems
• Assist in the training of staff on new procedures and ensure completion of training
• Maintain project schedules and trackers related to integration activities

What is Required (Qualifications):
• Bachelor?s degree in life sciences or related field
• Minimum of 5 years' experience in an FDA-regulated medical device environment
• Strong verbal and written communication skills
• Knowledge of FDA regulations and ISO 13485 standards
• Ability to work independently and collaboratively within a team

How to Stand Out (Preferred Qualifications):
• Experience with electronic documentation and training systems
• Familiarity with 21 CFR Part 11 and computer/quality system software management
• Knowledge of new product development documentation
• Proficiency in Microsoft Office and technical document applications like Adobe Acrobat
• Awareness of EU regulations related to medical devices

#MedicalDevices #QualityAssurance #CareerAdvancement #CompetitiveBenefits #RegulatoryCompliance

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