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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We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
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