The Senior Quality Engineer executes and coordinates Quality Engineering functions with a focus on continuous improvement of sterile and non sterile products and processes for MXC site. Leads the execution of initiatives and projects to enhance quality performance. Assures compliance to all applicable regulatory requirements and standards (ISO13485, MDSAP, 21CFR Part 820 FDA ). Partnering with QC and Manufacturing Engineering to manage continuous process/quality improvement programs, corrective and preventive (CAPA) activities in process as well as customer requirements. Participate in the internal audit program as Internal Auditor, support external audits (customer and third parties) as required.
- Bachelor Degree: Engineering, Manufacture, Industrial or related, Administration
- Minimum 5 years of Quality Control/Engineering experience
- Experience in Medical Devices
- ASQ Certification (CQE), Six Sigma Green Belt or Black Belt is a plus
- Internal / Lead Auditor ISO 13485:2016
- MDSAP knowledge
- English: 90%
- Office Windows: Word, Excel, Power Point
- Advanced SAP
- ETQ Reliance, AS400
- Strong leadership
- effective communication
- Self driven
- Management skills / Decision Making