Antal has the pleasure of working with a leading medical device organisation who is looking to recruit an experience Quality Operations Manager for their plant in Germany
The responsibilities include, but not limited to;
- Supervises the business’s Quality Engineering teams for Operations and NPD support.
- Ensures regulatory compliance and consistency of QA approaches across NPD programs, manufacturing transfers and during the production/distribution phase.
- Develops the support strategy and manages QE resources for New Product Development (NPD) projects and for Cost Improvement Projects (CIP). Ensures appropriate QE representation on product development teams and CIP teams.
- Manages and supports the Operations QE activities during manufacturing transfers and for day-to-day production/process controls.
- Interfaces with Supplier Manager during supplier qualifications and for ongoing supplier management activities.
- Applies quality engineering principles and techniques to ensure that the client’s products meet the performance specifications and regulatory standards throughout the product lifecycle.
- Utilizes quality engineering methods to ensure that the product design is transferred into manufacturing processes that are capable of reliably delivering products that are safe and consistently meet the performance requirements.
- Applies risk management, change control and validation principles and techniques throughout the entire product lifecycle (from development over design transfer to manufacture and distribution).
- Applies, maintains and improves procedures for consistent and effective implementation of quality system and regulatory requirements in the area of responsibility. Supports quality system improvement projects.
To be successful in this role candidates must come from an engineering background with at least 10 years industry experience, with at least 5 years within a quality position. Although out client is within the medical field it is ideal but not essential to have this sector experience, however an understanding of product transfers as well as working with NPD is important with at least an understanding of a manual people driven production environment.
It is essential for any candidate to have a strong communication skills and prior experience leading a team across a diverse environment.
There will be elements of process improvement so any project management experience would be advantageous.