Description
This is a new position with strong potential to go permanent! This position will be responsible for providing quality engineering support and leadership for operations. The ideal candidate will be able to utilize root cause analysis and determine CAPA in relation to supplied material and manufacturing Issues. The ideal candidate will have a strong understanding of quality systems, regulations, and industry standards.Requirements:
- BS in Science or Engineering (or related field)
- Minimum of 3 years experience in Quality Engineering within the Medical Device Industry.
- Strong understanding of ISO 13485
- Exceptional communication skills
- Strong mechanical aptitude and methodical problem solving skills
- Strong leadership ability
Responsibilities:
- Work with suppliers to drive CAPA
- Ability to use qualification/validation testing to provide direction to suppliers and other resources.
- Coordinate efforts to develop and continuously improve manufacturing processes using tools such as DOE, FMEA and SPC.
- Ability to identify and manage risk via FMECA or other risk management tools
- Lead investigations into non-conforming material
- Offers statistical guidance to test protocols and reports
If you, or anyone you know are interested, please get in contact with me as soon as possible via email, as all first round interviews will be confirmed by the end of this week!