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