About the role
As a Lab Instrumentation - Medical Device Validation Test Lead, you will make an impact by ensuring regulatory compliance and validation of software used in medical laboratory instrumentation. You will be a valued member of the Quality Engineering and Compliance team and work collaboratively with cross-functional stakeholders across regulatory, engineering, and business teams.
In this role, you will:
· Lead the development and execution of validation and test strategies for medical device and laboratory instrumentation systems
· Document and validate software in compliance with EMA guidelines and GxP regulations
· Author and maintain validation documentation, including test cases, specifications, infrastructure diagrams, and data flow diagrams
· Perform risk assessments and proactively communicate risks to stakeholders
· Provide technical leadership and mentorship to team members on validation and compliance practices
· Collaborate with cross-functional teams to ensure seamless integration of regulatory requirements
· Manage testing milestones, reporting, and ensure timely delivery of compliance outputs
· Drive continuous improvement of validation processes, frameworks, and tools
Work model
At Cognizant, we strive to provide flexibility wherever possible, and we are here to support a healthy work-life balance through our various wellbeing programs. Based on this role’s business requirements, this is an onsite position requiring work at a client or Cognizant office in Highland Heights, Kentucky.
The working arrangements for this role are accurate as of the date of posting. This may change based on the project you’re engaged in, as well as business and client requirements. Rest assured; we will always be clear about role expectations.
What you need to have to be considered
· Proven experience in medical device or laboratory instrumentation validation within a regulated GxP environment
· Strong expertise in validation lifecycle documentation, including test cases and compliance artifacts
· Solid understanding of EMA guidelines, regulatory compliance, and IT SOPs in pharma or medical device domains
· Hands-on experience in performing risk assessments and validation activities
· Excellent technical writing and documentation skills
· Strong communication skills with the ability to collaborate across cross-functional teams
· High attention to detail with a focus on accuracy, compliance, and quality
These will help you stand out
· Experience in regulatory affairs or compliance management operations
· Exposure to audit readiness and regulatory inspections
· Ability to create infrastructure and data flow diagrams
· Experience working in global delivery models (onshore/offshore collaboration)
· Continuous improvement mindset with the ability to drive process optimization and innovation
We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.
Salary and Other Compensation:
Applications will be accepted until June 15th, 2026
The annual salary for this position is between $83,250 to 131,500 depending on experience and other qualifications of the successful candidate.
This position is also eligible for Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans.
Benefits: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
Medical/Dental/Vision/Life Insurance
Paid holidays plus Paid Time Off
401(k) plan and contributions
Long-term/Short-term Disability
Paid Parental Leave
Employee Stock Purchase Plan
Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Über Cognizant
Cognizant (NASDAQ: CTSH) i ist ein Technologiedienstleister und Entwickler von KI-Lösungen. Wir schlagen die Brücke zwischen KI-Investitionen und echtem unternehmerischem Mehrwert, indem wir ganzheitliche Full-Stack-KI-Lösungen für unsere Kunden entwickeln. Mit unserer fundierten Branchen-, Prozess- und Engineering-Expertise integrieren wir die spezifischen Anforderungen von Unternehmen passgenau in Technologiesysteme. So entfalten wir das menschliche Potenzial, erzielen greifbare Ergebnisse und sichern globalen Unternehmen in einer sich rasant wandelnden Welt den entscheidenden Vorsprung. Erfahren Sie mehr unter cognizant.ai oder @cognizant.
Zusätzliche Informationen zur Beschäftigung
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