Quality Engineer

Shift:             Morning shift
Duration:   06 months contract with possible Extension
 
 
Job Description
 
Quality Engineer
* Responsible for Quality System maintenance.
* Performs root cause analysis and implementation of corrective action for process related issues.
* Identifies statistical methods relevant to the manufacturing process.
* Responsible for continual improvement activities to enhance the Quality System.
* Develops and performs training to build quality awareness throughout the company.
* Interfaces with Manufacturing, Research and Development and Engineering to ensure transfer of newly developed products that are in accordance with approved data and analysis.
* Conducts audits, including closing out audit findings, creating audits finding reports and works with cross functional teams to determine proper corrective and preventive actions.
* Assists in creation and maintaining quality documentation.
* Implements and maintains Statistical Process Control (SPC) for products and identifies potential process improvements.
* Conduct Active Pharmaceutical Ingredient product review.
* Evaluate impact of process improvement effort and manufacturing deviation on process validation and product design.
* Demonstrates good communication and project management skills.
* Collaborate with team members to support company goals.
* Develop experiments by applying full and fractional factorial techniques (DOE).
* Must be regular and punctual in attendance and adhere to all employee handbook policies.
 
Qualifications
* Bachelor of Science degree in Chemistry, Chemical Engineering, Material Science or related discipline.
* 3 5 years experience in quality engineering role in chemical, rubber, or plastic industries.
* ASQ Certified Quality Engineer, or are currently pursuing certification is preferred.
* Knowledge of ISO 9000.
* Working knowledge and experience with LEAN, Six Sigma methodologies.
* Working knowledge in Design of Experiments (DOE), and ability to manage implementation of improvements.
* Assist in validation processes including TM validation, manufacturing process validation, cleaning validation.
* Proficiency working with Microsoft Excel, Word.
* Experience with Minitab or other statistical software strongly desirable.
* Understanding of statistical process and quality control principle.
* Skilled in metrology tools.
* Ability to work effectively in a team environment.
* Ability to identify problems and communicate solutions in a constructive and positive manner.
* Attention to detail; excellent organizational and record keeping skills.