QARA Executive

Skills:

Quality Assurance, Risk Assessment, Regulatory Compliance, Auditing, Problem Solving, Attention to Detail, Communication Skills, Analytical Thinking,

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 +001, 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