Company Summary: This Blue-Chip Biotech is looking to grow the Quality team in their Michigan Plant with a brand-new Quality Engineer opening. This location manufactures pediatric & therapeutic powder products, including several life-saving metabolic products and some that are sole sourced for global distribution. As a Quality Engineer, you will get the chance to be involved in all aspects of the manufacturing operation - from assessing equipment needs, to documenting installation, qualification, and ongoing validation of equipment and processes.
The Quality Engineer will be responsible for:
- Interfacing with Safety Regulatory Agencies as required ensuring compliant product is released.
- Implementing product quality plans, documents, and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
- Implementing Process Monitoring Systems by identifying critical process steps which could result in manufacturing defect sources and devising methods to reduce process variation to reduce/eliminate the cause of defects.
- Leading/Assisting in writing, executing, and analyzing several types of protocols (i.e., engineering studies, verification protocols, validation, etc.)
- Reduces and controls manufacturing process defects (scrap, nonconforming material, customer complaints) by assisting efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
- Contribute to the development of appropriate reliability program for the division/site.
The Quality Engineer should have the following qualifications:
- Bachelor's degree or higher in a relevant field.
- Minimum 2 years industry experience in life sciences or other highly regulated industries.
- Relevant experience in Quality Assurance, Manufacturing, Engineering, or mixture thereof.
- Working knowledge of applicable regulations, compliance requirements, quality systems, and engineering / quality principles as relates to applicable manufacturing environment (preferably consumable goods).
- Growth opportunity with chance to start leading projects.
- Exposure to all levels of projects, from simple to total design changes.
- Robust rewards and recognition program for employees.
- Vigorous onboarding and continuous training & development.