Manufacturing Engineer

Immediate 6-8+ month contract opportunity in the metro west area of Boston, Massachusetts for a Quality Engineer with a minimum of 1-3 years experience in medical quality role. The right candidate is responsible for managing the customer complaint failure analysis process for assigned product families; coordinating investigations with the External Manufacturer (EM); monitoring trending of product performance data and providing interpretive summaries of results; ensuring compliance with policy, procedures, and regulations applicable to Post Market Surveillance EM complaint handling, and working with EM partners to manage CAPA issues associated with external complaints. Bring your organizatrional skills to a great team. This is a great assignment in very convenient location for the right individual!

RESPONSIBILITIES

- Sustain product complaint investigation activities for the External Manufacturer (EM) Complaint Investigation Site (CIS)
- Manage failure investigations including root cause determinations and documentation of findings
- Interpret and evaluate the product analysis, and recommend the need for additional actions including initiating CAPA's and working with EM partners to drive their closure
- Develop protocols/plans/procedures/requirements for testing of returned customer complaint units in support of company's quality program
- Works cross-functionally (EM's, engineering, clinical/medical) in identifying and resolving issues

REQUIREMENTS

- BS/BA in Engineering and/or Science Related discipline and/or equivalent experience with 1-3 years experience in a quality role
- 1+ years in the medical device industry OR solid background in QSR and MDD Quality System requirements
- Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio)
- Able to communicate at all organizational levels
- Travel may be required 5-15%

BENEFITS