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Danaher Corporation Associate Manager I - QA (Validation) in Bangalore, India

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXper t® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).

This position is for Cepheid 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 skilled 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 Sqft.

Job Description:

Cepheid is looking for a Software Quality Manager to join our product software quality team developing molecular diagnostic applications. This position reports to Product Software Quality Director in Sunnyvale, USA. You will be 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.

Essential Job Responsibilities:

  • Responsible for the Validation of Product Software Systems

  • Defines and oversees validation architecture and software compliance from system perspective.

  • Define validation schedule, engage stakeholders to seek agreement on deliverables and responsibilities

  • Participate in Validation to ensure the software meets user needs requirements of user workflows for a regulated environment

  • Influences key stakeholders to drive quality improvements

  • Participate in internal and external audits as a subject matter expert for Software

  • Act as an advisor to direct reports, and may become actively involved, as required, to meet schedules and resolve problems.

  • Receive assignments in the form of objectives with goals and the process by which to meet goals.

  • Administer company policies that directly affect subordinate employees, recommends changes to policies, and management reviews work to measure meeting of objectives.

  • Interact with other supervisors and functional peer groups, with the Interaction normally requiring the ability to gain the cooperation of others.

  • Lead the team to successfully deliver project releases on time and with desired quality

  • Build the team and develop capabilities of the team members

What We Are Looking For:

  • BA/BS degree or equivalent work experience in Computer Science or related field

  • 8+ years of relevant work experience in software validation testing

  • 2+ years of proven experience in leading major projects in regulated environments

  • Ability to work on issues where analysis of situation or data requires review of relevant factors.

  • Exercise judgment within defined procedures and policies to determine appropriate action.

  • Must have completed major projects with multiple release cycles and have working knowledge of software development lifecycle in FDA/ISO or other regulated field

  • Experience in cultivate and maintain contact with key customers, including IT and/or Business; working closely with vendors to complete required tasks

  • Experience in leading resolution efforts when issues are identified and escalate appropriately

  • Experience in proactively identify and assist in prioritizing opportunities to streamline testing and/or quality but still stay compliant

  • Must have experience in conducting risk assessment per ISO-14971 standards

  • Possess excellent analytical and troubleshooting skills, must be self-motivated, willing to learn new concepts, technologies and products quickly

  • Have strong interpersonal, writing and communication skills, as well as dedication to quality software and customer satisfaction

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 skilled people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and bring 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.

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 here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

Operating Company: Cepheid