Contract position: Large medical device manufacturer has a need for CAPA Owners/Investigators in Marion NC. This is a contract position expected to last 6 months, could be longer based on performance, possible temp to hire. Responsible for developing and performing the investigation, identifying the root cause(s) of the event, and documenting the results of the investigation in addition to being responsible for the CAPA (Medium and High only) through all phases of the CAPA process (Initiation through Closure). Will offer per diem if applicable! Will consider candidates that are not local! Great Contractor Benefits! Apply Now! Will hire ASAP!
Responsibilities for the Quality Engineer
- Develop the Investigation Plan and present the Investigation Plan and results at stage-gate review
- Accountable for project management aspects of the CAPA, complying with the CAPA process, communicating with leaders within Business and Quality.
- Assist in identifying the appropriate actions to mitigate or eliminate the root causes, and in determining an Effectiveness Plan for the actions (including effectiveness criteria and timeframe).
- Determine an appropriate due date
- Lead/facilitate the Investigation stage gate review
- Identify the scope of the CAPA
Requirements for the Quality Engineer
- Bachelor's degree (in science or engineering preferred) or equivalent experience
- 5+ years of experience in Quality, Manufacturing, Engineering or related field
- 5+ years experience as a CAPA Owner or Investigation Owner within the drug or medical device manufacturing industry
- Trackwise experience
- Complaints experience with parenterals is preferred
- Paid Vacation
- Health Insurance, and more...