Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Quality Engineer for a 6 month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
If you are someone who can see the big picture, thrives where solutions are needed, and wants to add value to healthcare; this role is for you! We need a problem solver who can build strong relationships with internal and external partners ensuring that project work results in the quality for which our client is known.
Responsible for the design, modeling, development and testing of a machine, structure or system.
Develops functional requirements.
Understands and applies standard engineering principles.
Creates simulations and prototypes to evaluate preliminary designs and test how a machine, structure or system operates.
Designs and tests components and integrates components to produce final product.
Monitors quality of products and controls the efficiency of processes.
Evaluates a design' s overall effectiveness, cost, reliability, and safety.
Investigates root causes of failures to maintain quality and recommend improvements.
Support manufacturing transfers for root cause investigation for manufacturing process related failures
Resolve nonconformances and CAPAs associated with the devices
Management/Review of First Article Inspections (FAIs)
Review of pFMEAs associated with the manufacturing transfer
Inspection plan updates in partnership with the supplier
Collect, analyze and summarize data to identify cause analysis to provide in depth descriptions of manufacturing anomalies
Track investigations within the nonconformance and/or customer complaints workflow to identify trends
Compose detailed, methodical descriptions of deviations and nonconformance through investigative writing
Create and explain data analysis through graphs, charts and pivot tables as needed
Read and understand descriptions, communications, reports, tables, diagrams, directions, regulations.
Bachelors in Engineering or related
3+ years of experience in related field
Experience in quality process development
Previous experience in process validation (PFMEA/DFM), process development, risk management for design decisions, PPAP, GD&T, testing and test method planning for validations highly preferred.