Job Description

Driven by the passion to improve quality of people\'s lives, WS Audiology continues to grow as market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively.We are looking for a Senior Analyst, IT Quality Management to lead quality assurance for IT projects, overseeing compliance, stakeholder management, and regulatory audit readiness. He/ she will be involved in defining and maintaining IT policies and procedures within the compliance framework.What you will do

• Oversee the computer system validation (CSV) process for IT initiatives, such as upgrades to ERP and MES systems, change management and ensure sustained quality throughout software development, configuration, and testing phases
• Liaise with stakeholders across the Quality Management System (QMS) and IT departments and provide comprehensive status updates, promptly escalating any issues requiring management attention and resolution
• Regularly 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, proactively 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.

What you bringExperience

• 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.

Personal competencies

• Comfortable working with people from various level 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.

Who we areAt 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.With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.Sounds wonderful? We can\'t wait to hear from you.WS Audiology is 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.

WS Audiology