Hello,
Greetings of the day!!!
One of our medical device clients is looking for the role of
Quality Engineer
Role: Quality Engineer
Location: Westbrook, ME
Shift Timings: Flight B (5:30 am-5:30 pm Thurs-Sat and every other Weds)
Job Description
- Support production with a resolution of quality issues in accordance with established procedures.
- Support production on the manufacturing floor, ensuring adherence to procedures and ensuring appropriate device history record (DHR) documentation.
- Supports line clearances, reworks, and inspections as required.
- Support the NC and CAPA processes by completing risk assessments, root cause investigations, and action plans.
- Reviews qualifications, validations, and other studies for technical content, statistical and sampling rationale, unintended impact, and clarity.
- Demonstrates commitment to the development, implementation, and effectiveness of Quality Management Systems per ISO, FDA, and other regulatory agencies.
Education And Experience
- Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science, or other technical field and at least 1+ year of experience in the medical device or other regulated industry.
- 2+ years of experience in medical devices.
- Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) Certification
Preferred Qualifications
- Knowledge of Agile programs.
- Working knowledge of Database software; Internet software; Spreadsheet software and Word Processing software.
- Working knowledge of FDA, CGMPs/QSR, and ISO quality system requirements.