Lead the Quality Assurance team at IDS Liège. Manage the Quality Management System(s) in Liège, reporting effectiveness to the Management Representative.
Maintain the Quality Management System (QMS) at Liège. Coordinate the activities of the QA operations team ensuring the Liège site and their products comply with appropriate international standards and regulations. Promoting Quality awareness.
The day-to-day management of the Quality Assurance function of IDS (Liège). Ensuring the company, and the company’s products, are compliant with the appropriate standards and regulations. Specifically:
- Maintenance of the IDS Liège Quality Management System in accordance with appropriate International Standards & Regulations and Group Standards
- Reporting to the Management Representative on the performance of the Quality Management System and any need for improvement
- Primary contact for all the QA aspects of Quality Compliance for the manufacture of IVD products, i.e. all aspects of the QMS
- The review of manufacturing batch records and the QA disposition of final product at IDS Liège.
- Interface with R&D and Operations to ensure the efficient and compliant transfer from R&D to IDS Liège Production of new products are in accordance with approved data.
- Ensure that new and existing products and processes comply with the relevant requirements of the quality management system.
- Supervision of the QA Operations team
- Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
- Facilitation of root cause analysis and implementation of effective CAPA for process related concerns.
- Assessment of change to ensure quality impact analysis, risk management and validation activities are identified and carried out.
- Develop and deliver training to build quality awareness. Developing cross functional approach to quality awareness and improvement.
- Conduct/Co-ordinate internal and Supplier Quality audits.
- Analyse failure, corrective and preventive action to respond to customer complaints. Including assessment of potential reportable events.
- Create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
- Changes are suitably assessed for impact to existing validated processes and product registrations
- Ensuring risk management activities are conducted.
- Preparation of QMS documentation; SOPs, QA reports etc.
Skills, Knowledge and Experience
- Bachelors degree (or equivalent) in Biochemistry or similar,
- Quality Engineer Certification (CQE) desirable,
- Lead Auditor ISO 9001 or ISO13485.
Skills & Knowledge
- Knowledge and experience in the application of, ISO 13485, IVDD, CMDR and FDA
- Knowledge of validation requirements and validation strategy as applied to medical device products, processes and equipment
- Excellent communication skills both written and spoken in French and English,
- Good attention to detail
- Good organization skills
- Confidence & assertiveness
- Action orientated
- Ability to complete tasks with limited supervision in an autonomous, self-managed role and ultimately have the strength of character to support QMS in an effective manner
- Ability to influence people, negotiate and lead meetings with internal and external contacts
- Ability to maintain excellent relations with key contacts both internally and externally
- Ability to work as part of a team, departmentally and inter-departmentally
- Ability to work under pressure and to strict deadlines
- At least 3 years experience in a quality role, preferably within IVD or the medical device industry.
- Experience of applicable regulations for manufacture and distribution of devices in EU, US and Canada.
- Experience of lean manufacturing, six sigma methodologies (green belt, or black belt desirable).
- Experience of validation – process, cleaning, equipment and computerised systems.
- Passion for Customers – We are passionate in understanding our customer needs and dedicated to providing excellent solutions
- Entrepreneurial – We consider the world around us as a set of opportunities, creating the chance to innovate and find solutions to generate customer and stakeholder value
- Excellence – We strive for excellence in all we do, to deliver the best results in order to be best in class!
To apply, please email [email protected]
|Job Role||QA Lead|
|Job Department||Quality and Regulatory|