QARA Executive
Job details
Job description, work day and responsibilities
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
Company address
You will be redirected to another website to apply.
Offer ID: #998543,
Published: 2 weeks ago,
Company registered: 9 months ago
