Reports To: Quality Manager
Location: Stratford, CT (Remote)

Job Overview
Under general supervision, assists the Directors of Quality and Engineering performing a range of activities to
help drive coordinated release of records from the Engineering Change process. This coordination involves
ensuring a variety records (e.g., including but not limited to Standard Operating Procedures, Work Instructions,
Bills of Materials, Purchasing Specifications and Test Plans) involved with a proposed change are updated,
released and trained on by appropriate personnel prior to the change being made Effective.
Responsibilities and Duties
 Participates in regular Engineering Change Meetings,
 Evaluates proposed Engineering Change order and works with the Assigned Engineer to coordinate
deliverables from cross functional teams including Quality, Marketing, Engineering and Production,
 Reviews document records to ensure they are complete and meet Regulatory and Quality
Management System requirements,
 Uploads documentation to appropriate records within the QMS software for final Review and Approval
 Serves as a resource for training new Assigned Engineers in the process.
 Manages the Engineering Change process template and submits revisions as necessary to ensure
continuous improvement as matures.
 Serves as a SME for Change records during Audits.

Qualifications
 Bachelor’s Degree in Engineering or Life Science
 3+ years Quality Assurance/Control experience in manufacturing environment.
 Understanding of ISO 13485 implementation
 Proficiency using Microsoft Suite (Word, Excel, PowerPoint)
 Proficiency in using ERP (Netsuite) and Quality (Qualio) enterprise software.
 Proficiency in using SolidWorks engineering software.
 Excellent oral and written communication skills
 Highly detail-oriented

Compensation/Benefits
Company offers a comprehensive and competitive compensation and benefit package.