QA Engineer

Vulcain Engineering Belgium
is looking for a
QA Engineer
to join its team
in the Leuven area.

As a
QA Engineer
, you will support the
QA Manager Production
in ensuring that Terumo Europe products fully meet
customer and regulatory requirements
related to both products and manufacturing processes.

You will contribute to maintaining and strengthening
product and process quality within the production environment
, based on defined control plans, with a strong focus on
zero defects and minimal waste
. Acting as a
key facilitator
, you will collaborate closely with
production, maintenance, and engineering teams
to support continuous improvement initiatives.

In this role, you will work on
diverse and challenging quality topics
, while benefiting from
structured follow-up and guidance
from one of our Business Managers, as well as
targeted training opportunities
aligned with your career development objectives.

ABOUT THE POSITION:

• Active role in continuous improvement of product and process quality through set-up of and active participation in improvement projects aligned with GPs requirements based on the GEMBA principles. Facilitates root-cause analysis and ensures improvements (from NC, CAPA, Kaizen, ...) are embedded in QMS, SOPs, work instructions, and plant wide control plans
• Trend analysis on internal non-conformities, product complaints and process/product characteristics to ensure that the quality system/control plan is updated to detect timely main product quality problems. Pro-actively communicate quality topics that require focus toconcerned departments (CFT, maintenance, facilities, logistics, engineering…) and actively participate in defining and implementing effective improvement actions (TIER, weekly CFT review meetings, QIM, ...)
• Interaction with PS sales and marketing and production to ensure that customer requirements are implemented in all stages of the production process. Completion of customer questionnaires and providing technical replies to questions from PS customers. Lead audits (customer audits, supplier audits where relevant) and facilitate inspections. Manage CAPAs and action plans after audits until effectiveness verification
• Provide pro-actively information and training about the current quality requirements and GMP[1]rules for Operations related departments. Ensure yearly GMP-training for all TE employees. Embed GEMBA and a right-first-time mindset on the shop floor.
• Handling product complaints of PS clients end-to-end with focus on root cause elimination and zero-defect objectives (see also point 1 and 2). Responsible for keeping records and complaint samples. Authorized for quality returns based on complaints. Active follow-up of the defined actions and countermeasures after audits and product complaints.
• Ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured before a device is released as delegated by the PRRC. Authorized for administrative release of finished products under supervision of the QA Manager. Ensure traceability, batch records, deviation handling, and approved release criteria.

ABOUT YOU:

• Higher scientific degree: (industrial) pharmacist, bio-engineer, industrial engineer, master in biomedical science with minimum first work experience or equivalent by experience.
• Experience with production in the pharmaceutical industry; medical devices or food industry and with quality assurance (control plan and continuous improvement cycle); GMP or HACCP rules
• Knowledge of quality systems (ISO 13485, QSR)
• Methodologies: RCA (5 Why, Ishikawa), CAPA, change control
• Soft skills: strong communication (shop floor & customer), stakeholder management, ownership, analytical, problem-solving, assertive yet constructive, attention to detail, sense of urgency.
• Languages: Dutch, English

ABOUT US:

Vulcain Engineering is a group specialized in the energy sector that supports companies active in Renewable & Nuclear Energy, Gas & Infrastructure through our Study Offices and Consultancy services. Vulcain Engineering Group is positioned as a transformation partner thanks to its ultra-specialization in strategic sectors which positively impact the transformation of our society and supports its clients in their transformation towards more sustainable and responsible models. Vulcain supports its clients throughout the entire life cycle of their projects, from design to commissioning, by integrating constructability and safety requirements right from the design phase.

In Belgium, our activities focus on consultancy services, delivering expertise in three main areas:

• Energy/Infrastructure
• Gas Renewables & Processes
• Life Sciences

With headquarters based in Brussels, and clients spread all over the country, we address key projects in the Belgian industry, offering our consultants the opportunity to work on challenging topics and discover different areas during their time at Vulcain.

Why would you apply?

• A competitive package including gross salary paid over 13,92 months and advantages such as a company car (and fuel card), representation fees, insurances, meal vouchers, eco cheques, a sectorial bonus
• A tailored career path within the company : opportunities to discover different business units, training, follow-up from your business manager, and a development evaluation every year
• A human-based company with slightly more than 120 consultants and synergies between the different business units