Are you an experienced Quality Engineer with a desire to excel? If so, then Talent Software Services may have the job for you. Our client is seeking an experienced Quality Engineer to work at their company in Paris, KY.
Position Summary: Under general supervision, develop, modify, apply, and maintain quality evaluation and control systems/protocols. Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Design and analyze inspection and testing processes, mechanisms, and equipment. Conduct quality assurance tests and perform statistical analysis to assess the level of control and manage product quality risks.
Primary Responsibilities/Accountabilities:
- Responsible for Quality System maintenance.
- Perform root cause analysis and implement corrective actions for process-related issues.
- Identify statistical methods relevant to the manufacturing process.
- Responsible for continual improvement activities to enhance the Quality System.
- Develop and perform training to build quality awareness throughout the company.
- Collaborate with Manufacturing, Research and Development, and Engineering to ensure transfer of newly developed products according to approved data and analysis.
- Conduct audits, close out audit findings, create audit finding reports, and work with multi-functional teams to determine proper corrective and preventive actions.
- Assist in the creation and maintenance of quality documentation.
- Implement and maintain Statistical Process Control (SPC) for products and identify potential process improvements.
- Conduct Active Pharmaceutical Ingredient product review.
- Evaluate the impact of process improvement efforts and manufacturing deviation on process validation and product design.
- Demonstrate good communication and project management skills.
- Collaborate with team members to support company goals.
- Develop experiments by applying full and fractional factorial techniques.
- Assist in validation processes including TM validation, manufacturing process validation, and cleaning validation.
Qualifications:
- Bachelor of Science degree in Chemistry, Chemical Engineering, Material Science, or related field required.
- 3-5 years experience in a quality engineering role in chemical, rubber, or plastic industries preferred.
- ASQ Certified Quality Engineer, or currently pursuing certification preferred.
- GMP experience preferably in Pharma.
Preferred:
- Knowledge of ISO 9000/ AS9100.
- Knowledge and experience with LEAN, Six Sigma methodologies.
- Familiarity with Design of Experiments (DOE), and ability to lead implementation of improvements.
- Proficiency working with Microsoft Excel, Word.
- Experience with Minitab or other statistical software strongly desirable.
- Understanding of statistical process and quality control principles.
- 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.