Quality Specialist - Business Quality Quality · Lynge, Copenhagen Region, Denmark

Are you eager to make a significant impact by shaping and advancing our Business Quality function, ensuring the delivery of high-quality products that provide Wonderful Sound for All? Join us, one of the industry's leading hearing aid manufacturers, as a Quality Specialist in our Business Quality team.

Who we are
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. With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

The role
In this role, you will play a critical role in maintaining and improving our quality management system (QMS) while ensuring compliance with regulatory requirements.

This position offers an exciting opportunity to work across various departments and contribute to the continuous improvement of our processes with a chance to influence how we work and be a significant part of enhancing our global processes.

Your responsibilities will include:

• 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

Your profile
To succeed in this role, you are a quality expert, with a strong understanding of quality management systems and regulatory requirements.

Experience

• 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

Personal competencies

• 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
  

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.

Department
Quality

Role
Business Quality

Locations
Lynge, Copenhagen Region, Denmark

Employment type
Full-time

Contact Nanna Fyrsterling