Description
Responsibilities:- Partner with R&D and Engineering teams to develop and transfer manufacturing processes to external contract manufacturing organizations. Ensure process development and transfer activities are based on sound quality engineering principles and in compliance with applicable regulations and standards.
- Develop and update process development and transfer documentation such as:
- Standard operating procedures, work instructions, and specifications
- QC test plans, acceptance criteria, and reports
- process and equipment validation plans, protocols, and reports
- Design change plans, requests, and reports
- Manufacturing process flowcharts
- Interface with cross-functional teams and external Contract Manufacturing Organizations to support routine product manufacturing. Ensure product manufacturing meet company quality expectations as well as applicable regulations and standards
- Travel: must be willing to travel up to 50 percent of the time
- Minimum of 5 years working experience in a process and / or quality engineering role in the medical device industry
- Experience with FDA (QSR), ISO 13485, MDD, and related regulations / standards
- Ability to work effectively with cross-functional teams as well as external corporate partners. Experience working with external contract manufacturing organizations preferred.
- Detail-oriented. Ability to multi-task effectively.
- Proven track record of resolving technical and / or quality-related issues in a timely and effective manner
- A thorough understanding of problem-solving and quality improvement tools as well as quality systems. This includes working knowledge and experience with the following:
- CAPA
- Production and Process Controls
- Risk Management
- Change control processes
- Process / Equipment Validatio
To find out more about Real please visit www.realstaffing.com