Overview
Quality Specialist Jobs in Hasselt, Flemish Region, Belgium at BIMONA
Title: Quality Specialist
Company: BIMONA
Location: Hasselt, Flemish Region, Belgium
Are you a skilled Quality Engineer with significant experience in managing New Product Introduction (NPI) processes, such as APQP, PPAP, or MSA? Do you possess a solid understanding of quality management principles, validation strategies, risk assessment, and change control? If you’re a proactive problem-solver with strong communication skills, we want you to join our team.
Key Responsibilities:
Ensure that all quality requirements are implemented throughout the various stages of the NPI process, guaranteeing alignment with customer expectations.
Collaborate with internal teams to make sure all quality standards and the company’s QMS are consistently met, including ISO9001, ISO15378, and cGMP guidelines.
Develop and maintain a comprehensive framework for risk management and control plans to ensure product quality at all stages of development.
Approve and review key documents such as validation papers, process flow diagrams, and product specifications to maintain consistency.
Thoroughly document all aspects of the NPI process, including control plans, capability studies, and any design changes made during development.
Work across departments to continuously improve the quality of products and optimize related processes.
Customer-Focused Responsibilities:
Serve as the primary point of contact for customers regarding quality issues during the NPI phase, ensuring their specifications and requirements are met.
Ensure that customer needs are accurately reflected in all validation documents and key project deliverables.
Coordinate the necessary documentation for customer approval (such as PSW, PPAP, and material certifications) before the product launch.
What We Are Looking For:
Essential Skills:
At least 5 years of experience in a quality role, particularly within the NPI or product development sector.
Strong customer focus with excellent communication and negotiation abilities.
A proactive approach with a hands-on mentality to solving quality-related issues.
Excellent analytical skills and the ability to identify and resolve potential quality problems.
Experience collaborating with international, cross-functional teams.
Preferred Qualifications:
Familiarity with product development methodologies such as APQP/PPAP.
Experience in the pharmaceutical or medical device industries is advantageous.
Fluency in English (both written and spoken); knowledge of Dutch or French is beneficial.
Understanding of relevant QMS standards such as ISO9001, ISO15378, and other applicable standards (e.g., ISO17665).
Interested?
[email protected] this position is also possible on freelance basis.