SalaryLocationKarlsruheIndustryPharma, Biotech & HealthcareJob Description
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.
Due to the nature of the products this role will be working with our client is looking for an individual who has a good understanding of a mix of manual and automated production and a high varying product types.
Individuals will need to be operational focused, hands on and have the ability to be the link between the technical R&D/Engineering teams and production to ensure the smooth running of the site.
This is an exciting opportunity to join a global business which will offer an opprotunity to help drive continuous improvement, raised compliance and lead a dedicated and skillful team.