Vacancy expired!
IKCON TECHNOLOGIES INC delivers exceptional IT services and solutions that provide clients with definite edge over competitors and promoting highest standards of quality. We are currently looking for an Quality Engineer with one of our clients in Remote, Remote If you are actively looking for opportunities, please send us your updated resume with your contact details. JOB TITLE Quality Engineer CITY Remote STATE Remote TAX TERMS C2C/W2 EXPERIENCE 7+ INTERVIEW MODE Telephonic and skype JOB DESCRIPTION Responsibilities:
- Support production with 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.
- May participate on design transfer and improvement project teams. Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
- May participate on design transfer and improvement project teams.
- Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
- Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field or the equivalent combination of education and experience.
- P1: 1+ years' experience in the medical device or other regulated industry.
- P2: 2-5 years experience in the medical device or other regulated industry.
- P3: 2-5 years experience in the medical device or other regulated industry. Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) Certification
- 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 Strong technical writing.
Vacancy expired!