Quality Engineer

Overview:
The Quality Engineer position is an advanced position whose major purpose is to ensure all department procedures and testing is in compliance with defined regulations. The Quality Engineer will aid in project management for chemical characterization testing as well as review/sign off on department testing protocols and reports related to chemical characterization. The North Haven Laboratory Services department is located in North Haven CT and directly services manufacturing locations worldwide. The Quality Engineer works both individually and as part of a team.

Roles and Responsibilities:
Responsible for seeing that all tasks are performed in a manner that complies with Corporate Policies
Knowledge of standards that the North Haven, CT North Haven Laboratory Services Group uses in routine testing (FDA Guidelines, ISO Standards, ASTM Standards)
Assist with ISO 17025 lab accreditation and subsequent maintenance
Provide project management for chemical characterization testing
Generate or Revise SOPs as necessary
Review of protocols and testing reports to ensure quality
Help ensure departmental compliance with local EHS procedures
Help facilitate CAPAs and preventive actions as necessary
Respond to inquiries from regulatory and operations.
Provide assistance to the Sr. Supervisor, Manager, and other Specialists with reports and/or paperwork.

Education and Experience:
Education required/preferred: BS Degree in Science
Experience: 2-4 years' experience in a quality role within a testing laboratory.
Preferably knowledge of ISO 10993-18, ISO 13485 and ISO 17025.