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?
annick@bimona.be this position is also possible on freelance basis.