
Senior Quality Assurance Specialist
11 hours ago
We are seeking a Senior Quality Assurance Specialist to join our Compliance, Quality and Regulatory team (CQR) for an exciting assignment within medical device development. The primary role of this position is to be responsible for timely planning and proper execution of test engineering in medical device development projects, based on identified and agreed needs to fulfill objectives at the project level.
Key Responsibilities Include:
- Act as Functional Test Lead on device projects
- Execute Test Engineering Work Packages
- Plan, execute, review and report on testing
- Drive strategic improvement opportunities, establish best practices, and share knowledge
- Act as process or subject matter expert
- Act as strategic test partner to client's device project teams
Main Job Tasks
As Senior Quality Assurance Specialist at Capgemini, you will:
- Act as functional test lead on device projects and represent Test Engineering and Test Execution teams in projects throughout the development process
- Coordinate all deliverables with functional method validation leads and lab technicians and be accountable for project investigations
- Execute test engineering packages and participate, contribute and provide input to specifications, project plans, protocols, and reports
- Identify and drive improvement opportunities, complex solving, and create new guidance
- Ensure training for the test team in expertise areas
- Lead and facilitate strategic test-related project decisions
Requirements and Qualifications
Capgemini believes that you have a degree in Mechanical/Biomedical Engineering or a related engineering discipline, with 2-5 years of experience in test engineering within medical device development, including the following aspects:
- Tests and measurements
- Verification of requirements
- Data analysis & statistics
- Test standards and regulations
- Requirements engineering
- Medical device design control
- Project management
- Navigating a GMP-regulated environment
- cLEAN
- Business understanding and end-to-end mindset
- Establishing and enabling strategy
- Defining and driving process improvements or digitalization
Excellent understanding of medical device regulations and standards, such as 21CFR820, ISO13485, and ISO17025, and proven track record of successfully managing testing within medical device development projects. Strong communication skills and leadership abilities, effectively collaborate with cross-functional teams, stakeholders, and external partners.
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