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Senior IT Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Senior Analyst, IT Quality Management to join our team at WS Audiology. As a key member of our IT department, you will be responsible for leading quality assurance for IT projects, ensuring compliance, stakeholder management, and regulatory audit readiness.
Key Responsibilities:- Oversee the computer system validation (CSV) process for IT initiatives, including upgrades to ERP and MES systems, change management, and ensuring sustained quality throughout software development, configuration, and testing phases.
- Liaise with stakeholders across the Quality Management System (QMS) and IT departments, providing comprehensive status updates and escalating any issues requiring management attention and resolution.
- Produce mandated compliance reports on a monthly, quarterly, and other periodic basis, in accordance with relevant regulatory guidelines.
- Facilitate thorough reviews of requirements and design artifacts, validating their applicability, accuracy, feasibility, usability, clarity, and testability.
- Collaborate closely with stakeholders to compile necessary artifacts, evidence, and documentation, ensuring readiness for periodic regulatory audits (e.g., FDA, TUV, GMP, ISO, etc.).
- Develop and uphold IT policies, Standard Operating Procedures (SOPs), and Work Instructions within the overarching framework of IT and QMS compliance.
- Minimum 3 years of experience in IT Computer System Validation (CSV) and/or Change Release Management background in software requirements, development, and/or testing activities in a Regulated industry, preferably Medical Devices or Healthcare.
- Track record as contributor in providing IT Computer System Validation (CSV) and/or change management support in a senior analyst capacity.
- Experience and/or certification in ISO 13485 is preferred.
- Good Documentation Practice knowledge and ITIL v3 or v4 certification is an added advantage.
- Comfortable working with people from various levels of management, from operational and working level to senior management level.
- Able to work alone and with minimum supervision/guidance.
- Ability to handle issues from beginning to closure.
At WS Audiology, we provide innovative hearing aids and hearing health services. Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.
We are an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status, we firmly believe that our work is at its best when everyone feels free to be their most authentic self.
