Quality Engineer - Katalyst Healthcares & Life Sciences
Boston, MA 02108
About the Job
Responsibilities:
- 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 organization.
- BS in Science or Engineering with 5+ years of Med Device or Life Science Quality Management.
- Quality Engineering supporting manufacturing.
- Some Supervisory experience is highly desired.
- Class 3 Med Device experience with electro-Cardio device experience is also highly desired.
- Experience with Post Market Complaints, Supplier Quality, CAPA is required.
Source : Katalyst Healthcares & Life Sciences
