position Title: Quality Engineer Work Location: Westford MA Assignment Duration: 12 months (possibility of extension) Work Arrangement: Onsite
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, subassemblies 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.
Additional Details
2-3 years minimum of Quality Engineering experience, preferrable in Medical Device Manufacturing.
I will accept experience in Pharma or Electronics.
Relevant experience must be in a highly regulated industry.
They should have experience with working on and executing tasks for projects, risk review, CAPA, and problem solving.
Please don’t submit candidates with 15 years’ experience or have recently held Manager or above jobs, as they will be considered overqualified.
Skills: Risk assessment review, Correct/Preventative Actions, inspection plan creation, documentation change management, problem solving/DMAIC, project management, time management
General Description of Work:
This candidate will be working on several high quality impacting projects at the Westford Manufacturing facility.
They will be a part of our post-market “Sustaining Quality Engineering” team and be supporting projects related to post-market updates to our products.
This includes maintenance of risk documentation, MPIs, design change evaluations, and support of complaint investigations and analysis.
This person will be expected to be prompt, organized, independent, and an aggressive problem solver.
We need a candidate with a proven track record of coming up to speed quickly, strong work ethic, and a dedication to supporting life-saving medical devices
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.