QARA Executive Job

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

Information above is Internshala's interpretation and paraphrasing of what we found on the shared link.