Quality System Integration Specialist - Contractor

Part Time Remote - US

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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