Advanced Quality Engineer Team Leader

Job description

Job Description:

·     Managing a team focused on R&D transferred projects moving to production &  Suppliers Quality assurance within the site

·     Supporting engineering cross-company projects acting as a quality specialist for both Hardware and consumables manufacturing.

·     Interface with R&D, sustaining and engineering, to support new product introductions and product & process changes with the intent of improving performance or quality, cost reductions and yield's improvement.

·      Interact with sustaining R&D and engineering on a root cause failure investigations.

·     Leading transfer and project quality plans

·     Initiation and follow-up on Corrective & Preventive Action internally and with suppliers - CAPAs/SCARs.

·     New supplier evaluation, qualification and supplier quality audits execution

·      Engineering changes review and approval related to production and new product instructions  

·     Review process validation protocols, support process verifications and validations, approve verification and validation reports.

Special Role Characteristics:

·     Team leader, management capability skills

·     Responsible, projectoriented, capable of self-management

Role  Requirements:


* 3-5 years’ experience in QA Production Processes within a manufacturing company, preferable experience working with R&D.

* Proven experience working with suppliers and Contract-Manufacturers
* Familiar with Validation processes:  IQ, OQ, PQ, MSA, GR&R
* Familiar with Office applications, ERP applications.

* Mechanical or Electronics Engineer. Formal Quality Engineering education, CQE preferred.

* Good understanding of ISO, familiar with FDA requirements preferred

* Familiar with the Quality tools, such as: FMEA, Lean manufacturing, Kaizen, DFM

* Excellent English as a working language – reading, writing and speaking.