Plan, develop, implement and monitor continuous improvement projects under Lean and Six Sigma methodology and philosophy of operational excellence, value improvement projects, processes and product transfer, implementation of new technologies related to RDI, it is also responsible for carrying out research related to the process and general support for the completion of manufacturing objectives within the quality system and regulatory requirements.
Necessary Duties and Responsibilities include the following:
- Report and Monitoring acts or unsafe conditions.
- Perform the duties following the guidelines of the Quality Management System.
- Behave according to the Company Ethical Charter.
- Propose projects to improve all aspects of the manufacturing process and reinforce the performance of operational indicators such as safety, yield, availability, cycle time, cost among others through practical use of the Lean and Six Sigma methodologies and tool box, as well as data analysis, design of experiments (DOE), FMEA studies, data extraction and analysis as well as Statistical Process Control (SPC) methods.
- Propose any other projects to support the achievement of company strategic objectives.
- Lead, plan, execute and control the projects assigned by the Sr. Supervisor Process Engineering and Training such as Value Improvement projects, Operational Excellence projects, continuous improvement projects, transfer projects, new technologies implementation projects and/or RDI related projects between others.
- Execute process engineering activities for the leaded projects which may include, but not limited to: process & product qualification protocols and reports development, operators training & qualification coordination, process & product qualification execution coordination, first articles development and coordination, DCC initiation & follow up, as well as other aspects applicable for any project.
- Prepare and present projects result reports to supervisor and staff managers involved in projects assigned.
- Collect, organize, and analyze technical information to support, design and development projects related to products manufacturability and new processes implementation.
- Support any manufacturing related activities during interdepartmental projects. Participate actively in the revision of quality system support documentation and participating in edition and/or approval DCC process.
- Perform and document the investigations of process deviations or non- conforming material to provide a disposition according to quality guidelines.
- Coordinate with vendors and suppliers any kind of purchase of equipment, material, or parts required for projects execution.
- Perform operator training and qualifications for the process engineering projects.
- Execute and participate in process and product qualification.
- Execute and participate in first article development.
- Collect and organize technical information to support design and development projects related to product manufacturing and new processes implementation.
- Perform and edit process engineering experimental tests.
- Execute and collaborate in manufacturing operations during process and product qualification, first article development and experimental tests.
- Perform raw material and tools inspections as required.
- Representation of the department when needed.
- Perform any other activity that the Sr. Supervisor Process Engineering and Training considers necessary.
Relationships and Roles:
- Direct report to the Sr. Supervisor Process Engineering and Training.
- Coordinate and work along with all departments of the company.
- Coordinate and work along with vendors and suppliers for project executions and development.
- When needed, responsible for communicating with customers, vendors and other external contacts or departments.
Job Specifications:
- Bachelor’s degree in Industrial Engineering, Chemical Engineering, or other related area.
- At least two years of experience in related positions.
- Knowledge of ISO 9001, ISO 13485, FDA, CE Mark standards and GMP´s.
- Experience in controlled production environments per ISO 14644, is a plus.
- Willingness to travel and work in a global team of professionals.
- Intermediate to Advanced speaking and writing English skills. Other languages are a plus (French, Portuguese, others).
- Computer knowledge is required, spread sheets, word processor, other utilities, basic knowledge of commercial software package (i.e. Windows or similar) and basic computer configuration.
- Good communication skills both oral and written.
- Problem Solving skills.
- Leadership and ability to drive teams.
- Ability to handle confidential information.
- Ability to prioritize and manage concurrent projects.
- Oriented to results.
