QARA Executive
3 months ago
Job Description
Job Title
QA & RA
No of Vacancy
1
Job Location
Boisar
Years of Experience
2-4 years
Working Days
Monday to Saturday
Job Purpose
A role combining Quality Assurance and Regulatory Affairs, more often found in the Medical Device sector
Roles & Responsibilities
- Apply technical solutions to problem solving
- Apply technical solutions to quality improvement projects
- Use technical writing skills to clearly describe technical information
- Analyze customer complaints, identify trends and execute corrective actions
- Understand standards and their application to medical devices
- Planning, protocol generation, testing and report generation for medical devices
- Generation and maintenance of technical files for medical devices
- Review and update technical files in line with EU medical devices regulatory requirements
- The use of harmonised standards when compiling a technical file in compliance with the MDD
- Ensuring that records are filed in accordance with site procedures
- Supporting R&D
Education and Experience
- Engineering / Science qualification
- 3 - 7 years experience within R&D / QA/ RA/ Compliance or Validation function in a Medical Device Environment
- Excellent technical writing experience within a medical device environment
- 3 - 7 years experience in Risk, Clinical and Biocompatibility an advantage
- Must have knowledge of ISO 13485
- Must have Skills:- USFDA, ISO 13485, ISO 9001, Product Development, Capa, Quality Assurance, Process Excellence, Six Sigma Black Belt, Project Management, CDSCO, MDD/MDR, Clinical, PMP
Skills
- Strong communication skills
- Ability to work well under pressure
- Attention to detail
- A desire to keep learning
- Flexibility
-
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