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Senior Engineer - Quality & Regulatory Affairs

7.00 to 12.00 Years   Mumbai City   30 Apr, 2021
DRAEGER INDIA PRIVATE LIMITED
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

The position is required for assisting in Quality management of Manufacturing set up -Processes for all the areas of Design, development, testing and production Regulatory requirements of Medical Devices.Tasks and Responsibilities

  • Preparation ,implementation & Maintenance of Quality management System as per ISO 9001,13485,ISO 14001,ISO45001/OHSAS18001.
  • Setting up inhouse Quality Assurance plan & Processes.
  • Ensure products meets Regulatory requirements as per EU MDR / FDA.
  • Technical file preparation and submission.
  • Provide support in Risk management and V&V of the product.
  • Provide Training to employees on QMS processes.
  • Conduct Internal Quality Audit.
  • Post market surveillance , customer complaints, product complaints & CAPA.
  • Manage field actions.
  • Approval of products in the country.
  • Take up improvement projects & Initiatives.
Position RequirementsEducation -Engineering degree in any field preferably Mechanical/Electrical /Electronics/Medical Electronics.Related Experience - Experience in Quality Assurance and regulatory 5-10 years in amedical device organization.Skills Requirement -
  • Good knowledge of Quality standards like ISO 9001,13485 , Quality Management system requirements & Audits.
  • Good knowledge of EU MDD/MDR requirement and FDA regulation.
  • Aware about the standards ISO14001 & OHSAS 18001.
  • Knowledge about the Quality Control & Quality assurance activities.
  • Good communication skills.
  • Logical & Rational.
  • result oriented.
  • Attention to details.

Keyskills :
regulatory requirementsregulatoryquality managementiso internal auditorcontinuous improvement culturekaizenroot cause analysistestinglean manufacturingsix sigmamedical

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