*Job Description for Quality Engineer*
*Urgently Hiring Quality Engineer*
We are seeking a high energy *Quality Engineer* for our client based in Westford, MA Location . Our client is one of the top Pharma companies in the USA.
*Responsibilities for Quality Engineer*
The purpose of this position is to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards.
This position will also support device complaint investigation and failure analysis as required
Develop incoming inspection processes and document incoming inspection activities. Provide in-process QA support to include inspection and document review. Complete final acceptance activities.
Manage the sterilization process, including validations and product sterile loads. Track nonconforming material and lead Material Review Board (MRB) efforts
3-5 yrs work related experience, UMDR, Med Device, Regulated Environment, FMEA/ FMCA
Job Type: Contract
Pay: $45.00 - $46.00 per hour
* Health insurance
* 8 hour shift
Ability to commute/relocate:
* Westford, MA: Reliably commute or planning to relocate before starting work (Required)
* Quality Engineering: 2 years (Preferred)
* CAPA, line support, root cause analysis: 2 years (Preferred)
* Med Device, Pharma industry: 1 year (Preferred)
Work Location: One location
- Failure Analysis
- Failure Mode Effects Analysis
- International Standards
- Quality Management
- Iso 13485 Standard