Quality Assurance Lead

Air Liquide; Town of Belgium (WI); On-site; USD 80,000 - 100,000; Full time

Job summary

Air Liquide is seeking a Quality Assurance Lead in the Town of Belgium, Wisconsin. The role involves maintaining the Quality Management System according to GDP and ISO standards, managing documentation, handling complaints, and conducting audits.

The ideal candidate will have a Master's degree in Science, 3-5 years of experience in quality related to medical devices or medicines, excellent communication skills, and proficiency in Dutch and English.

Qualifications

• 3-5 years of professional experience in a quality environment related to medical devices and/or medicines.
• Open personality, reliable and pragmatic.
• Ability to define objectives and allocate resources efficiently.

Responsibilities

• Maintain the Quality Management System according to GDP and ISO standards.
• Manage document management and complaint handling processes.
• Perform GDP self-inspections and internal audits.

Skills

Transversal leadership

Excellent communication skills

English language proficiency

Dutch language proficiency

Analytical skills

Stress resistance

Education

Master in Science or equivalent

Job description

## Quality Assurance LeadApplylocations: Belgium, Zemsttime type: Full timeposted on: Posted Todayjob requisition id: R10092520## How will you CONTRIBUTE and GROW?As Quality Assurance Lead, you are part of the Benelux Pharmaceutical / Quality Department and you report to the Quality & Safety Manager Benelux. You are responsible to maintain the Quality Management System according to the Good Distribution Practices (GDP - medicines) and ISO 13485 / MDR (Medical Devices as a distributor) in the Home Healthcare Belgian affiliate.You lead the following processes:* Document management* Complaint and CAPA management* Preparation of the external audits / inspections* Internal auditing* Management of change* Supplier Qualificationand keep them up to date by:* managing the version of the manuals, procedures and forms ;* creating and following the Corrective and Preventive actions with the concerned managers ;* following the external complaints and animating their resolution with the concerned departments ;* performing internal audits ;* preparing external inspections and following the related action plans ;* animating the management of change process ;* being involved in the training & qualification process ;* raising quality awareness among the personnel ;* maintaining inventory integrity in Zemst by monitoring storage conditions, managing expiry dates through FEFO rotation, and overseeing pest control protocols;.* being part of the supplier's qualification and evaluation process by setting up the criteria and by following-up the supplier documentation.You perform the GDP self-inspections on our sites where we store medicines and medical devices (under the responsibility of the Responsible Person). You follow and check the GMP production activity in Zemst (under the responsibility of the Qualified Person). As an important project, you work in close collaboration with the Benelux Quality & Safety Manager in order to harmonize the quality processes between Belgium and the Netherlands.## \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_## ## Are you a MATCH?Your profile:* Master in Science or equivalent* 3-5 years professional experience with at least a first experience in a quality environment related to medical devices and/or medicines.* Excellent transversal leadership and structuring qualities.* Open personality, no-nonsense, reliable.* Good communication and social skills. Can influence others positively, easily obtains the cooperation of others, cares about people as well as results.* Command of the Dutch and English language in word and writing. French is a plus.* Pragmatic, quality and cost conscious. Defines objectives and the means to achieve them, anticipates future situations, draws up work plans and efficient use of available resources or allocates them efficiently.* Acts according to plan and sets priorities, makes efficient use of methods, systems and resources.* Analytical, helicopter view, flexible (not a black and white thinker).* Team player, stress resistant, and steadfast.#LI-MC1**Our Differences make our Performance**At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world. We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.### About UsA world leader in gases, technologies and services for Industry and Health. Through the passion and diversity of its people, Air Liquide leverages energy and environment transition, changes in healthcare and digitization, and delivers greater value to all its stakeholders. Join us for a stimulating experience: you’ll find a world of learning and development opportunities where inventiveness is at the heart of what we do, in an open, collaborative and respectful environment.****Discover what your professional journey at Air Liquide could be** here**!****