At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges.
Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings.
As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
Learn about the which makes everything possible.
Job Title : Quality Assurance Lead
Job Location : India-Karnataka-Bengaluru
POSITION SUMMARY :
The Quality Assurance Lead is responsible for performing and supporting Quality assurance and Quality Systems activities.
This position supports Operations activities such as non-conformance investigations and dispositions, CAPA requests, and is responsible for the maintenance of Quality System documentation as related to batch record compliance and ensuring accuracy and traceability of data and in accordance with the requirements of India MDR, IVDD / IVDR / ISO 13485(ISO).
This position will learn and Drive / facilitate the Problem-Solving Process to solve complex problems and will be able to drive process improvement projects within the department.
Growth and development opportunities in this group are driven by our core behaviors and Danaher policies.
This position is part of the Quality Organization and will be in Bengaluru, India. Our mission is to ensure that performed Quality Systems activities are done by focusing on the quality of the product, the internal and external customer needs, and according to the Quality System, IVDR and ISO regulations.
ESSENTIAL JOB RESPONSIBILITIES :
Originate and implement local and global standard operating procedures and work instructions.
Regularly monitor, investigate, and review non-conformance activities and generate CAPAs based on trends / issues identified from operations, MRB and drive them to closure.
Proactively identify potential problems and drive continuous improvement, utilizing the CAPA and other processes.
Drive and facilitate the Problem-Solving Process to solve complex problem.
Accountable for batch records review and documents, for completeness and compliance with regulatory requirements and ISO requirements to support release of raw materials, work in progress and final products.
This includes reagents, components, and instrumentation-related products.
Manage internal audit for site.
Manage internal and external suppliers audit and non-conformance activities
NOTE : All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
TRAINING RESPONSIBILITIES : (REQUIRED)
Complete all assigned and required training satisfactorily and on time
MINIMUM REQUIREMENTS :
Education and Experience :
Master’s degree in science (Biochemistry, Biotechnology, Pharmacy), medical or technical field and 10+ years’ Quality assurance experience.
Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable
Knowledge and skills :
Hands on Experience on IVD product testing.
Working Knowledge of current GxP regulations for Invitro Medical Devices and ISO 13485 QMS.
Must be flexible to work off-shifts and weekends as per production Schedule.
Schedule orientated (able to consistently maintains schedules and meet timelines)
Strong interpersonal skills, Effective organization and Communication skills are essential.
Good skills in English language
Knowledge of Microsoft Word and Excel
Strong multi-tasking and attention to details skills.
PREFERRED REQUIREMENTS :
Experience in Validation Process, Non-conformance process, MRB, and CAPA process.
Experience representing their department during Internal and External Quality system audits
Medical Device or Clinical Laboratory experience.
Experience in the medical device industry, knowledge of ISO 13485 and MDR, 2017
Experience in leading continuous improvement efforts, in both quality systems and products.
Knowledge of the process of establishing facility QMS certifications.
Cross functional experience with products and manufacturing processes to influence change at all levels within the organization Visio and Project knowledge desirable.
Danaher Corporation 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 70,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage.
We generated $20 B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 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.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win.
As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.
Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
If you’ve ever wondered what’s within you, there’s no better time to find out.