```html
About the Company
3D Systems Belgium (Recruitment through WilsonHR) is looking for a motivated QUALITY ENGINEERING MANAGER.
3D Systems Belgium, formerly LayerWise, is a dynamic and leading enterprise, specialized in 3D Printing of metal components. 3D Systems Belgium is part of the international company 3D Systems. 3D Systems is a renowned developer of 3D-printers and a contract manufacturer of 3D printed parts. The synergy of both activities makes us a strong innovation partner for customers in the industrial and healthcare sector. We believe in a culture of open communication, supporting each other and the value of trust & respect for the individual.
About the Role
The 3D Systems site in Leuven, Belgium is looking for a skilled Quality Engineering Manager reporting directly to the Director of Global Quality to lead a team of quality professionals responsible for ensuring Quality Systems are implemented and customer-designed products are transferred to production successfully. You will use your knowledge of quality engineering, risk management, project management, and lean six sigma to positively influence production and post-production activities to achieve high customer satisfaction.
Responsibilities
* Assist quality management in setting the strategy for the Global Quality organization
* Provide oversight for the development and maintenance of quality programs, systems, processes, and procedures that conform to established internal and external standards and guidelines
* Provide leadership in the continual improvement of the Quality system
* Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance
* Develop and monitor appropriate quality metrics for review by management including inputs into the management review process
* Lead Quality Management Reviews quarterly, Change Control process, complaint handling and CAPA investigations
* Participate in the transfer of new projects into manufacturing and continue providing quality engineering support until product obsolescence
* Make use of appropriate quality tools, such as DOE, SPC, hypothesis testing, and capability studies to measure, monitor, improve processes
* Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations
* Lead the response to customer inquiries and escalations for product issues experienced by customers
* Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits
* Review and provide feedback on Quality Agreements with customers
* Collaborates with the Global Quality Team in the QMS Harmonization and eQMS transition projects
Qualifications
* Bachelor’s Degree in Engineering, Science or technical field. Masters degree in engineering or related field preferred
* 8+ years of related work experience in regulated, cGMP environment such as medical device, pharmaceutical or aerospace/defense
* 3+ years of direct management/supervisory experience required
* Excellent knowledge of English both written and spoken, good knowledge of Dutch is a plus
* Experience with CAPA investigations
* Strong problem-solving, communication and project management skills
* Lean Six Sigma Black Belt preferred
* Able to analyze and chart data using MS Excel or Minitab.
* Working knowledge and practical experience in the use of Medical Device regulations (CFR 820.30, ISO 13485:2016 / EU MDR; etc;) and/or Aerospace standard (AS9100).
Required Skills
* Strong problem-solving, communication and project management skills
* Excellent knowledge of English both written and spoken, good knowledge of Dutch is a plus
* Experience with CAPA investigations
* Lean Six Sigma Black Belt preferred
Preferred Skills
* Working knowledge and practical experience in the use of Medical Device regulations (CFR 820.30, ISO 13485:2016 / EU MDR; etc;) and/or Aerospace standard (AS9100).
Pay range and compensation package
A competitive salary and additional non-statutory benefits.
Equal Opportunity Statement
We offer a challenging job in a young and dynamic team. Career opportunities in a global company with growth opportunities.
```