Validation Engineer

Quality System Engineer

Overall Responsibilities:
Develop, implement and maintain quality system requirements on assigned areas of manufacturing, supplier management, process validation and new products introduction. Areas of responsibility may include: non-conforming product, CAPA, calibration systems, supplier auditing, sterility, measuring techniques, design of tools and gages, training, statistical support, quality planning, experimental protocols, facilitation of root cause analysis, risk assessment and complaint investigation. The validation engineer assignments will include manufacturing support, working with new product development, validation and supplier management.

Professional Experience &

Educational Requirements:

BS degree in sciences, business, engineering or related technical field. Experience in the medical device industry is a must. At least 3 years QE experience preferred. Minimum of 3 years validation experience with medical device company. Need to have experience with validating machinery and equipment. Knowledge of FDA’s QSR and ISO regulations preferred. Working knowledge of geometric dimensioning and tolerancing, blueprint reading, basic metrology, gage design, design/process FMEA and quality plan development.

Strong statistical ability and experience including gage repeatability and reproducibility, statistical process control, process capability and design of experiments. ASQ certified quality engineer, lean manufacturing and/or six sigma certification preferred. Demonstrated excellent interpersonal and communication skills. Knowledge of manufacturing materials and processes preferred (machining, sheet metal, electropolishing, passivation, hard coating, anodization, etc).