Description
The Senior Operations Quality Engineer must meet the following requirements:- Bachelor's Degree in Science or Engineering (or related field)
- Minimum of 5 years experience in areas of Supplier Quality and Manufacturing Quality Engineering in the medical device industry or (related industry).
- Strong mechanical aptitude and methodical problem solving skills
- Excellent organization, time management and project management skills
- Strong communications skills
- Must be team oriented, but also be able to work independently
The Senior Operations Quality Engineer will have the following responsibilities:
- Interface with suppliers to drive corrective/preventive action
- Offer technical direction to suppliers utilizing qualifications and validation testing
- Review and create test plans and reports such as First Article Inspection, qualification, and validation
- Identify and execute improvement activities such as tooling changes, vendor process changes and certifications
- Ability to identify and manage risk via FMECA or other risk management tools
- Lead investigations into non-conforming material
- Strong understanding of process control tools and analytical techniques (i.e. SPC, DOE)
- Responsible for providing input to design and manufacturing documentation (material specifications, drawings, inspection and manufacturing procedures)
- Offers statistical guidance to test protocols and reports
To find out more about Real please visit www.realstaffing.com