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Associate QA Manager
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 Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Associate QA Manager is responsible to provide technical and managerial guidance to highly skilled individual contributors and reinforces technical direction of the group. Ensures projects are completed on time within budget and manages the development of processes and procedures to implement functional strategies. Resolves operational problems through collaboration with Software Engineering managers and coordinates resources to meet operational objectives within own area. This position reports to Software Quality Manager in IDC, Bengaluru
This position is part of the Cepheid Quality Team and will be located at Danaher India Development Center (IDC), Bengaluru. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.
In this role, you will have the opportunity to:
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Responsible for the validation of Computer Systems / Product Software Systems.
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Defines and oversees validation architecture and software compliance from a system perspective. Participate in validation to ensure that the software meets the user’s needs and workflow requirements in a regulated environment.
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Define the validation schedule, engage stakeholders to get an agreement on deliverables and responsibilities, and influence key stakeholders to drive quality improvement.
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Participate in internal and external audits as a Software subject matter expert.
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Act as an advisor to direct reports and may become actively involved when required to meet schedules and handle problems. Administer company policies that have a direct effect on subordinate employees, recommend changes to policies, and management reviews work to measure meeting of objectives.
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Receive assignments in the form of objectives with goals and a process by which to meet goals
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Interact with other supervisors and functional peer groups, with the Interaction normally requiring the ability to gain the cooperation of others.
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Lead and build the team to successfully deliver project releases on time and with desired quality and develop capabilities of the team members
The essential requirements of the job include:
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BE/BS degree or equivalent work experience in Computer Science or related field
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8+ years of relevant work experience in Computer System Validation/ Product Software Validation and System Platform Testing.
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2+ years of proven experience in leading major projects in regulated environments
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Ability to work on issues where analysis of situation or data requires review of relevant factors.
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Exercise judgment within defined procedures and policies to determine appropriate action.
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Have experience in ISO-13485 and conducting risk assessment per ISO-14971 standards, must have completed major projects with multiple release cycles and have working knowledge of software development lifecycle in FDA/ISO or other regulated field like Must.
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Experience in cultivate and maintain contact with key customers, including IT and/or Business; working closely with vendors to complete required tasks.
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Experience in leading resolution efforts when issues are identified and escalate appropriately and proactively identify and assist in prioritizing opportunities to streamline testing and/or quality but still stay compliant.
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Possess excellent analytical and troubleshooting skills, must be self-motivated, willing to learn new concepts, technologies, and products quickly. Along with strong interpersonal, writing and communication skills, as well as dedication to quality software and customer satisfaction.
Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.
Hybrid Job Posting Language:
At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.
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 Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) 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.
Operating Company: Cepheid
