Hello,
This is Preethi from Intellectt Inc. Please find the requirement details for the below position
Role: Quality Engineer
Location: Westbrook, ME
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.
Basic Qualifications
- Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field and experience in the medical device or other regulated industry.
Preferred Qualifications
- 2+ years' experience in the medical device or other regulated industry.
- Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) Certification
Competencies
- 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.
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Thanks & Regards
Baby Preethi
Recruiter | Intellectt Inc
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Desk: 732-412-6999 Ext: 187
Direct: 732-200-2270
517 Route 1 South, Suite 1115 Iselin, NJ 08830.
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In my absence, you may contact Sandy | Lead | 732-592-6299 | *************