Quality Engineer

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?

this position is also possible on freelance basis.