The QA Engineering team has a significant role in ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms. This is done by collaborating, supporting, facilitating, training, and communicating towards the best results by partnering with R&D.
The position is in Bangalore and is part of a team of 5 highly skilled engineers (India team). We are supporting design control and work collaboratively with our QA colleagues for Immunoassays, Blood Gas, Transcutaneous monitoring, and IT System solutions.
The position acts as a Quality Specialist within specific projects in product development with focus on the software.
This position reports to Senior Manager, QA in India Development Center Bangalore.Responsibilities
- 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 regulations applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system.
- Ensure that the projects and teams in IDC are Audit ready and provide support during the Internal and External audits of IDC
- Provide support in driving IDC specific Quality initiatives
- Demonstrate Danaher values and adopt DBS tools
Requirements for this positiona) Formal Education
The ideal candidate holds a M.Tech /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 can 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' Proficiencies / Skills / Experience
- 10 years of proven 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
- QA Design Control experience from the medical device or IVD industry or other similar regulated industries specifically in medical device software
- In-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe, and other key markets (FDA 21 CFR Part 820, ISO 13485, IVDR 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.
Drives projects forward to reach pivotal objectives and makes things happen by following throughc) Language
Proficiency in writing and speaking Englishe) Travel (required estimated % of time)
According to projects, but probably 5-10 days a yearKey Relationshipsa) Internal
QA in Bangalore & Copenhagen, R&D colleagues in Bangaloreb) External
R&D team in Copenhagen, Danaher and Radiometer group colleaguesCorporate Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.Equal Opportunity Employer
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The 'EEO is the Law' poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.Accommodations
Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 202-419-7762 or e-mail [Confidential Information] to request accommodation.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The 'EEO is the Law' poster is available .