For our client, an organization that provides filtration, separation and purification solutions that meet the needs of medical and industrial companies globally, we're looking for a Senior Customer Quality Engineer, at Medemblik.
As a Senior Customer Quality Engineer, you'll be a key player in the Quality Team, managing quality related processes with subcontractors who manufacture the company's products and manage customer questions, and partner with suppliers, customers and to Single-Use Technologies (SUT) manufacturing sites with members of all departments of the organization.
In this role, you'll manage all quality related processes regarding subcontractors, and as such, will have the following responsibilities:
* Customer Complaints related to the company's products manufactured by subcontractors
* Enable root-cause analysis at subcontractors, drive to root-cause and manage the implementation of CAPA's
* Manage and document product and process changes
* Facilitate FARA discussions and coordinate customer communications
* Ensure that all products, processes, methods and equipment are validated and remain in validated state
* Follow-up on the overall product quality of the sub-contractors
o Responsible to perform technical and QMS based subcontractor audits
o Support in subcontractor qualification and onboarding process
o Responsible to monitor, improve and develop subcontractors
* Customer Advocate / Voice of the Customer. Ensure alignment with customer requirements, where possible. Build and sustain strong relationships with SAM and KAMs. Manage customer questions related to SUT Expansion plans
* Master's degree preferably in Life Sciences fields
* More than 5 years of relevant experience
* Experience in Project Management
* Knowledge of ISO9001:2015 is required, and knowledge of ISO11137, ISO14644 and ISO14698 desirably.
* Lean Six Sigma knowledge is a plus
Valuable Personal Skills
* Strong working knowledge of quality assurance principles and practices, industry and international regulations and standards
* Proven track record in leadership, both direct as well as cross functional
* Effectively communicate highly technical information - verbally and in writing - to both non-technical as well as to technical associates.
* Ability to multitask and have problem-solving skills and have an analytical approach, rather than jumping to superficial conclusions.
* Fluency in English (written & spoken)
* Knowledge MS Office and statistical programs
* Being willing to travel 25-40% of your time, both domestically as well as internationally
* Will follow the applicable Health and Safety policy, safety rules and working instructions, and you're responsible for your own safety and for the safety of your colleagues by preventing risks and reporting any hazardous situation or unsafe behavior
If you're interested in working on a multifaceted role at an industry leading company, where you can transform your ideas into action and strive for your own development, then take this opportunity to join us in a journey of innovation.
T: 0626326600 or 023-7111190
When interested please react through the application process with your English resume.
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