For one of the biggest leading pharmaceutical companies worldwide, we are looking for a Supplier Quality Engineer. You will have a lot of interaction with the procurement department (supplier, budget control, ad hoc escalation, supplier issues, non-conformance, supplier performance, reports every quarter, preparing date, assessment of suppliers) and managing the engagement with the team management in the US and NL. The job offers a 12-month contract with extension. The company is in Leiden.
- Provide timely business support for the assigned CSS Supplier Quality Management (SQM) function globally.
- Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management.
- Lead the deployment of the SQM strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the CSS supply chain.
- Actively leverage talents and lead teams (SQEs and others).
- Collaborate with Strategic Sourcing/Procurement, R&D, Engineering/Technical Operations, Quality, Operations, business partners/stakeholders, and external suppliers to implement solutions and improve suppliers’ quality and overall service and performance.
- Proactively identifies, develops, and leads the investigation and resolution of supplier-related challenges, and implements appropriate Quality Engineering methodologies, statistical techniques, process capability analyses/improvements, DOE/process optimization, and other technical or Process Excellence (PEx) tools in support of supplier-related changes, risk management, product/process transfers, innovations, and continuous process enhancements to improve supplier reliability, minimize risks, and ensure sustainable sources of material supply capable of meeting or exceeding Quality, Compliance, and Business requirements.
- A minimum of a bachelor’s degree in Engineering, an Applied Science or a related technical and quality field is required.
- A minimum of 6+ years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation is required.
- Prior manufacturing, plant or technical background is required.
- Working experience in GMP regulated environment (Medical device, pharmaceutical, etc.).
- Demonstrated knowledge of manufacturing principles and practices, and procedures.
- Direct experience in plant and/or supplier GMP auditing is preferred.
- Broad experience with quality systems, including but not limited to validation, nonconformance, CAPA systems and investigations, laboratory controls, production and process controls, is required.
- Experience with documentation and technical writing skills, in a regulated compliance
- environment, is required.
- Component Qualification/Process Validation experience is preferred. New product
- introduction experience is desired.
- Prior experience with FDA inspections is desirable.
- Broad knowledge of Quality System Regulations and Supplier Quality Management principles are desired.
- Demonstrated ability to identify compliance risks and assess business impact, is required.
- English is a must have, Dutch is a nice to have.
- Able to work 1-2 days on site.
Project start date:
Short notice preferred
If you are interested in the above description, please apply with your CV and a letter of motivation.
PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?
For further information, please contact Sayf Idais at +31 (0)20 20 44 502 or by email at email@example.com