Overview
Quality Engineer Jobs in Covington, USA at millenniumsoft
Roles & Responsibilities
- Serve as the Quality Representative on project teams, ensuring Design Control principles are applied.
- Support Quality Department tasks, including generating RFS, ECR, and PQR documents.
- Create and review Quality System Documents, Product Documents, Test Methods, and Design History File documents.
- Develop and review validation protocols for processes, products, and stability studies.
- Conduct risk assessments (FMEA, FMECA, or FTA).
- Perform internal or supplier quality system audits.
- Ensure compliance with corporate, division, and department procedures.
- Interface with manufacturing facilities and other division locations.
- Stay updated on industry standards through professional organizations.
- Travel as required for job duties.
Experience Required
- 3-5 years of experience is preferred.
- Experience in FDA-regulated industries and product development programs.
- Knowledge of manufacturing processes and quality systems.
- Experience with writing process, software, and equipment validations.
Skills & Certifications
- Strong communication (verbal, written, and presentation).
- Ability to work independently and within teams.
- Understanding of engineering principles and regulatory requirements.
- Strong problem-solving and decision-making skills.
- Proficiency in mathematical analysis and basic applied statistics.
Eligibilities & qualifications
- B.S. in Engineering, Engineering Technology, or Science required.
- ASQ certification (CQE, CQA, CQM) preferred.
Title: Quality Engineer
Company: millenniumsoft
Location: Covington, USA
Category:
