Quality Engineer

About the role

Responsible to perform complaint investigation including reviewing and assessing Quality Notifications, DHR and Risk document in the instrument plant. Oversee operations and assure documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines.

Responsibilities

• Perform complaint investigation
• Oversee operations and assure documentation and procedures are followed
• Maintain and update documentation and procedures as required
• Assure compliance with internal Quality Policies and FDA/GMP guidelines
• Develop solutions to a variety of problems using policies and procedures for guidance

Requirements

• Minimum BS or BA in related field required with 2 years of experience
• Detail oriented
• Effective verbal and written communication skills
• Proven ability to develop solutions to a variety of problems of moderate scope and complexity
• Working understanding of Quality Systems Regulations (Good Manufacturing Practices, ISO, FDA)
• Professional certification (CQA, CQE, SQE, CQM, Six Sigma, etc.) is an advantage

Qualifications

• Must have effective verbal and written communication skills
• Must be self-motivated/directed, organized, detail oriented
• Must be able to work in teams and independently with minimal supervision

Skills

• Capable of using Microsoft programs

Benefits

• Not specified

Pay

• Not specified

Schedule

• Not specified