Quality Specialist

Quality Specialist

Danaher
Bengaluru / Bangalore India
10-13 years
Not Specified

Job Description


Job Title: Quality Specialist
Job location - Bangalore, India
Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions - decisions that in the end help save lives.
On a yearly basis millions of lives are touched by the information our solutions provide and that's a fact, we take very seriously; the more critical the setting, the greater the requirements are and that's why we've made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses.Our people
At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3200 colleagues are committed and dedicated to help realize life's potential.
If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you.
Radiometer offers a broad array of comprehensive, competitive benefit programs that add value to associates and their families lives.
Join our winning team and Follow us on LinkedIn!
This position is for Radiometer team located at Danaher India Development Center (IDC), Bangalore
IDC is a research and development center with the vision of accelerating product roadmaps across various Danaher business segments. Started in 2014, the center now hosts 500+ associates, for multiple Danaher operating companies focusing on Diagnostics, Life Science, and Environmental and Applied Science segments. The operating companies includes Beckman Coulter, Radiometer, Leica Biosystems, Danaher Digital, Hach, Leica Microsystems, HemoCue, Videojet and Cepheid.
The IDC workforce comprises of various product engineering teams, working on development of software and hardware components of cutting-edge products for, Immunoassay, Chemistry, Hematology, Molecular diagnostics, Oncology, Neurosurgery and Water Quality. IDC has evolved as center of excellence for Cloud and data analytics, with significant contributions to the key informatics solutions. The teams consist of highly hardworking software & hardware engineers and development managers. The teams are supported by local Product managers, Quality & Regulatory and Intellectual property specialists.
The inhouse teams works in close coordination with other global R&D centers at US, France, Germany, Japan, Australia, Denmark and Sweden. Located at the center of Bangalore IT HUB, IDC is housed at state of art facility, measuring 120 K
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.
Position Summary:
The position is located in Bangalore and is part of a team of 5 highly skilled engineers (India team). This position reports to Senior Manager, QA in India Development Center Bangalore. 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.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 position
a) 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 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' 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.
  • Travel 0-10% per year
  • Good Communication skills

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 .

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