Head of Quality
The Head of Quality is responsible to ensure Oystershell’s Quality Management System is compliant with the applicable regulations, in particular medical devices in Europe. The Head of Quality makes sure that products meet all customer and legal requirements.
You are responsible together with your team to ensure that the day-to-day quality business results are achieved.
You are part of the management team which leads the company; you report directly to the CEO.
Primary Responsibilities and Tasks
- With support of your team and your peers in the departments of Supply, Regulatory, and R&D, you are responsible for the Quality Management System and documentation
- You act as the Management Representative. The responsibilities of the Management Representative are:
- QMS Process Maintenance
- Reporting on QMS Performance
- Promoting Customer Requirements
- Ensure the promotion of awareness of regulatory requirements throughout the organization
- Performing the Management Review Meetings
- Together with the Quality team you are responsible for monitoring the Quality processes, supplier control, risk management and Audits (Supplier, Notified Body, Customer, Internal)
- You oversee the Technical/Quality agreements with suppliers/customers
- Identify process bottlenecks and plan and implement quality optimization projects
- You coordinate the Quality Department with other functional areas, such as regulatory, sales, supply, procurement, sourcing, datamanagement and finance
- People Management
Manage the quality team (QA Compliance Manager, Quality Managers, Quality Officers, Quality Assistants and QA Manager (US based)) to ensure the day-to-day quality results are achieved and processes are monitored.
- Business Management
- Plan and implement the overall quality strategy for the Oystershell group
- Determine key Quality KPIs, aligned with the company strategy
- Responsible for opex of the Quality department
Education & Experience
- Master in Science or equal through experience
- 10 years’ experience in a Quality function, preferably in a medical device/pharmaceutical company
- Min 3 years’ experience in leading a team
- Experience in business management: roll-out strategic plans, budgetary control, …
- Excellent knowledge of Dutch and English
- Good knowledge of ISO 13485/2016 standard
- Knowledge of international and regulatory regulations such as Regulation (EU) 2017/745 on Medical Devices
- Experience with CAPA, Change control process, complaint handling, supplier management and management of a QMS
- Experience in a manufacturing environment
- Continuous improvement mindset
Competencies & Expected Professional Attitude
- Learning attitude: curious and interested
- Pragmatic and hands-on
- Deadline oriented
- Team player
If you are interested in joining the dynamic team of Oystershell, please send your CV and motivation letter to email@example.com. Response and confidentiality are guaranteed.
Please note that we only accept direct applications.