Quality Engineer

Technical and Functional Skills

• Experience in a Quality Engineering role within Medical Device
• 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

• Good Documentation Skills
• Must have very good written and verbal communication skill

Entry level

Full-time

Quality Assurance