Quality Engineer - Katalyst Healthcares & Life Sciences
Boston, MA 02108
About the Job
Responsibilities and Requirements:
- The Quality Engineer position oversees quality functions for the company including, but not limited to, Complaint Handling, Process Improvement, Supplier Quality Management, Batch Record Review, reviewing Change Orders, Product and Process Development, CAPA and Quality System Improvement.
- This position will require direct involvement with daily quality requirements execution.
- The Quality Engineer is also responsible for maintaining compliance to FDA 21 CFR PART 820, ISO 13485 requirements and EU Medical Device Regulations for a Class III Medical Device company.
- Demonstrated leadership abilities and the ability to manage a team to achieve company goals.
- Collect and organize diverse information to solve problems, guide the organization, and ensure high product quality.
- Strong knowledge of quality engineering concepts and medical device requirements and the ability to train others on these concepts and requirements.
- Able to write clearly and concisely and be able to communicate across different levels of the organizations.
- BS in Science or Engineering with 5+ years of Med Device or Life Science Quality Management, or Quality Engineering supporting manufacturing.
- Some Supervisory experienced is highly desired.
- Class 3 Med Device experience with electro-Cardio device experience also highly desired.
- Experience with Post Market Complaints, Supplier Quality, CAPA is required.
Source : Katalyst Healthcares & Life Sciences