Description
This is a new position with strong potential to go permanent! This position will be responsible for providing quality engineering support and leadership in the areas of process and manufacturing quality. 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 5 years experience in Operations/Process Development and Manufacturing Quality Engineering in the medical device industry or (related industry).
- Strong understanding of ISO 13485
- Exceptional communication skills
- Strong mechanical aptitude and methodical problem solving skills
- Strong understanding of Quality Systems and Quality Engineering techniques
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.
- Analyze product designs to assist in the development and optimization of process technologies
- 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
- Review and create test plans and reports such as First Article Inspection, qualification, and validation
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!
To find out more about Real please visit www.realstaffing.com