qa engineer - medical devices in bangalore

randstad india
position type
apply now

bangalore, karnataka
Pharma, healthcare & lifesciences
position type
reference number
randstad india
apply now

job description

qa engineer - medical devices in bangalore

?Provide guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.

? Represent Quality Assurance in design and development projects and in cross-functional teams supporting new product development, agreeing and planning for requirement management and approving documentation.
? Collaborating closely with R&D, Operations and RA to assure high quality throughout the development process including design transfer and post launch activities.

? Take part in the Quality assurance activities as an active member of relevant project teams.

? Assessing overall product risk by facilitating the use of risk management tools and contributing to the risk management evaluations.

? Participating in quality training activities.

? Keep up to date knowledge of standards, regulatory requirements and directives applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system.

?To work on latest technology adherence.
Onsite Opportunity.
Highly skilled and professional attitude.
Flexible working hours

Client Introduction
?Client is a Denmark based fortune 500 organization who specializes into Life sciences, Biotechnology and Medical Devices. As a Senior Devops, you will be part of a software development team where you will have the responsibility for developing new and maintain existing functionality in our analyzer products.


?QA, 21 CFR, Medical device


?a) Formal Education
The ideal candidate holds an MTech /MCA/B.Tech/BE degree in engineering, with strength in product design processes of multi-disciplinary products. However, if the candidate has a good technical understanding and is able to learn the technical aspects in the products fast and to communicate in a technical organization, other education at university level relevant for QA work could be accepted.

b) 'Must Have' Competencies / Skills / Experience
- 4 to 5 years of experience as a quality assurance professional in a Healthcare domain
- Specialist in design control processes in one or more of the following areas: Risk Management, Usability, Requirement management, systems engineering and architecture, Cybersecurity, Validation and verification, Design planning.
- QA Design Control experience from the medical device or IVD industry or other similar regulated industries.
- In-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA 21 CFR Part 820, ISO 13485 and MDR)
- Must have knowledge and experience in working with ISO 14971 and IEC 62304
- Knowledge & experience on Agile/ Scrum SW development methodologies
- Process development and lean thinking.
- Structured person with skills for planning and visual management.
- Strong verbal and written communication skills