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Validation Test Lead – Lab Instrumentation / Medical Devices
Accepting applicationsCognizant · Kentucky, United States
Full-Time Lead aiarmatementorrf
Posted
27 May
Category
Test
Experience
Lead
Country
United States
About The Role
As a Validation Test Lead – Lab Instrumentation / Medical Devices, 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 and compliance team and work collaboratively with cross-functional stakeholders, including regulatory affairs, engineering, and client teams.
In This Role, You Will
Lead the development and execution of validation and testing strategies for regulated software systems
Document and validate instrument software in accordance with EMA guidelines and GxP requirements
Perform risk assessments and proactively communicate risks to stakeholders
Develop validation test cases, software specifications, and supporting documentation (including infrastructure and data flow diagrams)
Collaborate with cross-functional teams to ensure seamless integration of compliance requirements
Work model
At Cognizant, we strive to provide flexibility wherever possible and support a healthy work-life balance through various wellbeing programs. Based on this role’s business requirements, this is an onsite position requiring full-time presence 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 project and business requirements.
What You Need To Have To Be Considered
Proven lead-level experience in lab instrumentation or medical device software validation within a regulated (GxP) environment
Strong knowledge of EMA guidelines, validation lifecycle, and compliance standards
Expertise in technical documentation, validation test case creation, and specification writing
Experience conducting risk assessments and validation lifecycle documentation
Strong communication and stakeholder management skills across cross-functional teams
These will help you stand out
Experience in pharmaceutical or medical device industry environments
Familiarity with IT SOPs and regulatory audit readiness
Proven ability to lead teams and mentor members in validation best practices
Experience driving process improvements in testing frameworks and tools
Exposure to automation or innovative testing approaches in regulated environments
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
Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship.
Please note, this role is not able to offer visa transfer or sponsorship now or in the future*
Show more Show less
As a Validation Test Lead – Lab Instrumentation / Medical Devices, 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 and compliance team and work collaboratively with cross-functional stakeholders, including regulatory affairs, engineering, and client teams.
In This Role, You Will
Lead the development and execution of validation and testing strategies for regulated software systems
Document and validate instrument software in accordance with EMA guidelines and GxP requirements
Perform risk assessments and proactively communicate risks to stakeholders
Develop validation test cases, software specifications, and supporting documentation (including infrastructure and data flow diagrams)
Collaborate with cross-functional teams to ensure seamless integration of compliance requirements
Work model
At Cognizant, we strive to provide flexibility wherever possible and support a healthy work-life balance through various wellbeing programs. Based on this role’s business requirements, this is an onsite position requiring full-time presence 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 project and business requirements.
What You Need To Have To Be Considered
Proven lead-level experience in lab instrumentation or medical device software validation within a regulated (GxP) environment
Strong knowledge of EMA guidelines, validation lifecycle, and compliance standards
Expertise in technical documentation, validation test case creation, and specification writing
Experience conducting risk assessments and validation lifecycle documentation
Strong communication and stakeholder management skills across cross-functional teams
These will help you stand out
Experience in pharmaceutical or medical device industry environments
Familiarity with IT SOPs and regulatory audit readiness
Proven ability to lead teams and mentor members in validation best practices
Experience driving process improvements in testing frameworks and tools
Exposure to automation or innovative testing approaches in regulated environments
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
Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship.
Please note, this role is not able to offer visa transfer or sponsorship now or in the future*
Show more Show less