hireejobs
Register for Job
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

RA/QA Engineer

4.00 to 6.00 Years   Pune   02 Jun, 2021
Varian Medical Systems India Software Pvt Ltd
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

We are hiring RA/QA Engineer who will be responsible for minimizing risk to the organization associated with product design and realization efforts and assists in ensuring robust medical device product designs under governing domestic and international requirements.

Provides support and typically works as a member of one or more new product development and/or sustaining engineering projects. Typically serves as the quality representative on the project team and works closely with the project team leader.

Major on-going responsibilities for, but not limited to:

  • Is a member of Pune engineering team and has the responsibility and authority for ensuring Quality System requirements are established and maintained in accordance with applicable quality procedures of Varian Product Life Cycle (PLC)
  • Participate in reviews of designs and design documentation to ensure that all domestic, international engineering practices, Quality System documentation, laws and regulations are being met consistently.
  • Support Quality group during internal/external audits with respect to internal Quality System documentation and all appropriate regulations.
  • Review ECN s to ensure compliance to Quality System, QSR and International standards and requirements for Product Life Cycle (PLC) and sustaining activities.
  • Ensure that product development projects and changes to existing products are conducted in compliance with all appropriate regulations and standards.
  • Work with teams to ensure successful transfer of new products to manufacturing. Review production processes for quality of Process Validation.
  • Provide input to the creation of Design Verification and Validation protocols and test reports.
  • Provide guidance and direction for sample size and statistical analysis for testing.
  • Provide guidance and/or training to project teams on procedures, Design Verification and Validation, statistical methods and Design Controls.
  • Review Design History Files for conformance to applicable requirements.
  • Supports Regulatory Affairs regarding regulatory submissions e.g. 510(k) submissions containing medical device software.
  • Understand and be able to review software development lifecycle records for compliance with good documentation practices.
  • Maintain a complete awareness of the cost of quality and promote activities to monitor and reduce quality costs. Provide external supplier support as required.
  • May be responsible for specific SME (Subject Matter Expert) support, general improvement projects and support of CAPAs.

Qualifications:

Education : Bachelors Degree in Computer Science, Engineering or related technical field required. Master Degree or equivalent preferred.

Experience: 4-6 years

Candidate Profile:

  • Experience of working on either of healthcare software lifecycle phase like design and development, testing, or customer facing activities.
  • Experience of healthcare software (medical device software or EMR, EHR) related customer requirement gathering, solution development, verification and validation testing, customer acceptance, complaint handing is preferred.
  • Experience of working in regulated industry of medical device is added advantage.
  • Working knowledge of software development and/or electrical/mechanical engineering.
  • Experience of working with healthcare provider that follows FDA Design Controls, ISO 13485 and other medical device regulations.
  • Professional certification (i.e. SQA-Software Quality Assurance, Certified Internal/Lead Auditor for ISO 13485) is is added advantage.
  • Requires excellent written and verbal communication skills.
  • Ability relocate to work location to work with geographically diverse teams.
,

Keyskills :
new product developmentregression testingsoftware quality assurancecost of qualityproject teamsinspectionquality systemautomationtest casesproduct life cycledesign historyqualitycomputer sciencesoftware qualitysoftware development life cycle

APPLY NOW

RA/QA Engineer Related Jobs

© 2019 Hireejobs All Rights Reserved