Senior Quality Engineer - Katalyst Healthcares & Life Sciences
Boston, MA 02108
About the Job
Responsibilities and Requirements:
- A minimum of 4-6 years of related experience.
- Must have Process Validation experience.
- Good technical understanding of manufacturing equipment and processes.
- Knowledge of statistical software packages (e.g. Minitab) with the ability to preview, graph and analyse data and be able to present data that facilitates/drives decision making.
- Experience working in both an FDA and European regulatory environment in manufacturing/operations.
- A thorough understanding of GMP/ISO regulations and validation regulations.
- The ability to perform "hands on " troubleshooting and problem solving.
- Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook).
- In-depth knowledge of product/process Risk Management (FDA and ISO standards).
- Strong communication and interpersonal skills.
- Must have the ability to function in a team-based manufacturing environment.
- The ability to collaborate with all levels of management in a cross-functional team environment.
Source : Katalyst Healthcares & Life Sciences
