Quality Specialist - Business Quality
WS Audiology
- Lynge, Hovedstaden
- Permanent
- Fuldtid
- Act as the Local CAPA Officer, overseeing the implementation of CAPA systems, reviewing, and approving local CAPAs, and providing training to employees on CAPA processes
- Provide training to employees on non-conforming topics such as Root Cause Analysis (RCA), as needed
- Monitor Key Performance Indicators (KPIs) and conduct data analysis on non-conforming processes, including CAPA
- Perform global CAPA checks to ensure consistency and effectiveness
- Support the local Document Control Officer in the review, release, and approval process of documents
- Proactively initiate procedure updates in case of gaps, issues, or needed improvements in processes, or in the case of process changes via Change Request
- Coordinate documentation requests from customers or authorities for Lynge
- Minimum of 3 years of experience in Quality Management Systems (QMS), CAPA, non-conforming processes, etc., possibly within a manufacturing environment
- Familiarity with ISO 13485, Medical Device Regulation (MDR), and FDA Quality System Regulation (QSR)
- Proficiency in Microsoft Office Suite and experience with Document Control software is a plus
- Experience in managing projects from start to finish, ensuring they stay on track and meet deadline
- You are outgoing and can engage stakeholders effectively, guiding them through complex processes and fostering learning
- With a detail-oriented with strong analytical mindset, you are passionate about improving processes and ensuring compliance with industry standards in a pragmatic way
- Your strong organizational skills give you the ability to prioritize and manage multiple tasks effectively
- You have a proactive approach to identifying and resolving issues, with a continuous improvement mindset