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):
- Bachelors 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
We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
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.
Apply Now
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):
- Bachelors 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
We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
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.
Apply Now