Job Overview:
We are looking for a highly skilled Verification Expert to lead and manage the functional and performance verification processes for our cutting-edge hearing care devices.
The ideal candidate will have extensive experience in creating and reviewing Verification Plans and Reports, handling bug management, utilizing GAMP 5 and V-Model approaches, and coordinating risk assessments. Additionally, proficiency in managing offshore teams, fluency in multiple languages, and expertise in tools such as Visual Studio App Center, Noahlink, Jira, Confluence, and Polarion ALM are essential for success in this role.
Key Responsibilities:
- Write, review, and approve Verification Plans and Reports.
- Code queries for processing database in alignment with verification requirements.
- Demonstrate expertise in Bluetooth fitting equipment, specifically Noahlink by HIMSA.
- Engage with specialists, developers, and testers to understand and address the causes of issues.
- Drive the creation, verification, and implementation of solutions.
- Implement GAMP 5 and V-Model approach, covering Performance Qualification, Operational Qualification, and Installation Qualification.
- Oversee and execute Change Management processes within the verification framework.
- Risk assessments for projects and ensure proactive Corrective and Preventive Actions (CAPAs).
- Lead a team of manual testers for software verification.
- Coordinate test cases and activities among testers using Jira and Confluence.
- Supervise and document test runs, ensuring comprehensive coverage and adherence to project timelines.
- Manage onboarding and knowledge-sharing for team members.
- Effectively manage offshore teams located in Portugal.
- Facilitate communication, coordination, and collaboration across different geographical locations.
- Document test results using Polarion ALM.
- Utilize Visual Studio App Center for verification of mobile applications using hearing devices.
- Coordinate test material shipments between Switzerland and Portugal and within multiple Portuguese sites.
Qualifications:
- Bachelor's or Master's degree in a relevant field.
- Proven experience in functional and performance verification of medical devices.
- Experience with hearing devices would be a strong advantage.
- Experience in leading multinational, offshore teams.
- Ability to manage and coordinate diverse teams across different locations.
- Proficient in the use of relevant tools such as Visual Studio App Center, Noahlink, Jira, Confluence, and Polarion ALM.
- Strong communication and leadership skills.
- Fluent in English and Portuguese. Knowledge of either French or German would be a plus.