Quality Engineer (Must Have Project management skills with FDA knowledge)

Responsibilities

• Review and assess Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines 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.
• Conduct complaint investigations, assist in the investigation of manufacturing issues and provide data and input on technical issues and projects.

Requirements

• BS or BA in related field required with 4 years of experience, or MS with 3 years of experience required (project management experience preferred).
• Comprehensive knowledge of quality systems and relationship to business.
• Experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles.
• Ability to effectively manage time and handle multiple task assignments.
• Ability to translate quality requirements into product specifications and interpret Regulations, Corporate, Division and Department Procedures.

Qualifications

• Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).

Skills

• Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
• Capable of using Microsoft programs and ability to learn other systems.
• Working knowledge of statistical methods as well as statistical application software.
• Effective verbal and written communication skills.
• Ability to work in teams and independently with minimal supervision to obtain results as required.
• Self-motivated/directed, organized, detail oriented and have ability to multi-task projects.

Benefits

• 1st Shift
• 5+ Months Contract Term
• 40.00 Weekly Hours [Mon - Fri]

Pay

• To be determined based on experience and qualifications.

Schedule

• 1st Shift