Quality Engineer

Randstad Engineering has am immediate 12+ month contract opporunity west of Boston for a Quality Engineer with expertise in medical device. This is a great long term assignment in very convenient Metro West locatrion!

RESPONSIBILITIES

- Analyze Quality data related to external audits / inspections and industry trends and continually refine mechanisms for effective communication, messaging and management reporting.
- Develop, implement and maintain effective communication mechanisms to provide key information to the compliance community with regards to external audits.
- Apply Quality and Compliance principles to assigned projects, products or sites and guides them into implementation. Provide project direction, coaching, and mentoring for engineering and technical team personnel as appropriate.
- Serve as team member in supporting Quality and Compliance strategies, decisions and practices. Investigates, identifies, and implements best-in-class Quality Engineering practices as requested by management
- Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality and compliance issues.
- Support sites during audits / inspections as needed to ensure consistent messaging of Corporate related initiatives and also to drive consistent information communication to all sites.

REQUIREMENTS

- 5-8 years medical device experience with BS in Basic Sciences/Engineering or related discipline.
- Demonstrated use of Quality tools/methodologies and comprehensive working knowledge of FDA, ISO, MDD, CMDR, JPAL.
- Good familiarity with the FDA, ISO, MDD and understanding of US and International regulations including 21 CFR, 820, 210, 211, 11, as well as ISO 13485:2003
- Expert in all Microsoft Office programs, specifically PowerPoint, Excel and Visio as well as in depth knowledge of Share Point.