Quality Systems Engineer Jobs

Education: Mechanical or Industrial Engineering degree

Experience: 3-5 years

Must Have: MANGO, Trackwise, supplier quality knowledge

Self starter, solid communicator

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Responsible for assessing suppliers with self-assessment questionnaires and scoring RX-360 Questionnaires from suppliers

Maintaining and filing electronic supplier files in global database

Responsible for assisting Stoneham site with implementation of Quality agreements and Change Commitments with relevant suppliers

Working with Site manager on implementing pertinent SOPs for an ISO Quality Management System

Maintaining Monthly and Quarterly Metrics

Creating new purchase Specifications as needed and uploading existing Purchase Specifications into new Document Management system

The ideal candidate will possess the following:

4 year degree in engineering or technical discipline, or equivalent in combination of experience and education

Excellent technical writing and verbal communication skills.

Strong computer skills including experience with Microsoft Office applications and database software, Access, Sharepoint, Macros, etc.

Some project management experience.

Supplier Quality Management experience a plus

Experience developing and implementing a Quality Management System a plus.

Knowledge of regulatory standards including ISO 13485 and/or ISO 9001. Knowledge of FDA QSRs a plus.

Certified Quality Engineer a plus

Experience in applying Lean manufacturing and/or Six Sigma tools in a manufacturing environment will be a strong plus.