Volt Workforce Solutions Engineer, Quality in Westford, Massachusetts
Engineer, Quality in Westford, MA at Volt
Date Posted: 1/9/2019
Employee Type: Contingent
Location: Westford, MA
Job Type: Engineering Disciplines
Duration: 44 weeks
Date Posted: 1/9/2019
Job ID: 156620
Contact Name Volt Branch
Volt Workforce Solutions is partnering with a leading manufacturer of medical devices to hire a Quality Engineer for their Westford, Mass area. This is an exciting opportunity for the qualified candidate.
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.
Essential Duties and Responsibilities:
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. Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, sub-assemblies and contract processing.
Lead complaint investigations on returned product. Manage corrective action and quality improvement activities. Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing. Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics.
BS Degree, Electrical, Mechanical, Bio-medical preferred
1-2 years of experience working in a quality role within a regulated environment, preferably, medical or FDA
Volt is an Equal Opportunity Employer
In order to promote this harmony in the workplace and to obey the laws related to employment, Volt maintains a strong commitment to equal employment opportunity without unlawful regard to race, color, national origin, citizenship status, ancestry, religion (including religious dress and grooming practices), creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), sexual orientation, gender identity, gender expression, marital or parental status, age, mental or physical disability, medical condition, genetic information, military or veteran status or any other category protected by applicable law.