Quality Engineer

Technical/Functional Skills :

experience in a Quality Engineering role within Medical Device11

Experience working in a Supplier Quality or Continuity environment

Working understanding of QSR/ISO regulations, design assurance, FMEA, Process Flow, and product testing methods.

Experience in process validations: creating, reviewing, and approving protocols and reports, and execution of protocols.

Experience to include all components of production and process controls including, IQ, OQ, PQ, PPQ, manufacturing equipment software (CSV), and TMV/MSA.

Experience in pFMEA, manufacturing process flows, control plans, and quality records are required.

Expert knowledge of blueprint reading and geometric dimensioning and tolerancing

Knowledge of statistics, manufacturing process control and validation, and process capability

Medical device manufacturing experience

Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).

Ability to deliver, meet deadlines and have results orientation.

Able to communicate both orally and in written form to multiple levels of the company.

Microsoft Office Suite Experience

Generic Managerial Skills :

Good Documentation Skills.

Must have very good written and verbal communication skill.