Engineer, Quality
Share
Job Location:
Scarborough, ME - USA
Monthly Salary:
Not Disclosed
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Engineer Quality
Location (On-site Remote or Hybrid): Scarborough ME (Onsite)
Contract Duration: Contract until 12/31/2026
Work Hours: 8am - 5pm Monday - Friday
Location (On-site Remote or Hybrid): Scarborough ME (Onsite)
Contract Duration: Contract until 12/31/2026
Work Hours: 8am - 5pm Monday - Friday
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:
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
