What are the responsibilities and job description for the Quality Engineer position at Pentangle Tech Services | P5 Group?
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
- Good Documentation Skills.
- Must have very good written and verbal communication skill.