Location : Valley Cottage NY US 10989
Job Type : Temp/Contract to Direct
Reference Code : 21080-BZ1
Compensation : open - 45-55/h
Start Date : 06/20/2022
Hours : Full Time
Required Years of Experience : 3
Required Education : BS Engineering or Science
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Contract to direct position for a Regulatory Specialist for medical device manufacturing.
- Translate quality and regulatory requirements into quality assurance plans and instructions.
- Prepare and implement quality standards, operating procedures, work instructions and reporting systems.
- Conduct quality and regulatory training programs for personnel.
- Report in-house and field quality data and quality problems, recommend corrective action, and verify effectiveness of solutions.
- Conduct internal quality and vendor audits on a scheduled basis.
- Perform other duties as assigned.
Required Qualifications :
- BS Engineering or Science
- Internal Company orientation training.
- Training: ISO-13485 or similar quality system standard and quality auditing.
- External advanced QSR/GMP/ISO training.
- Related SOP training.
- Minimum 3 years experience with quality and regulatory affairs.
Intermediate Level Microsoft Office: Excel and Word.
Experience with internal auditing of Quality systems.
Contact: Bill Zukowsky