Overview:
We are seeking a highly skilled and detail-oriented Quality Engineer to join our team. As a Quality Engineer, you will play a crucial role in ensuring that our products meet the highest quality standards. You will be responsible for implementing and maintaining quality systems, conducting inspections, analyzing data, and collaborating with cross-functional teams to drive continuous improvement.
Responsibilities:
- Develop and implement quality management systems to ensure compliance with FDA regulations and industry standards
- Conduct quality inspections of raw materials, in-process components, and finished products
- Perform statistical analysis of quality data to identify trends and areas for improvement
- Collaborate with cross-functional teams to address quality issues and implement corrective actions
- Participate in the development and execution of validation protocols for equipment, processes, and software
- Support the development and maintenance of standard operating procedures (SOPs) related to quality assurance
- Provide training to employees on quality systems, procedures, and best practices
- Assist in the investigation of customer complaints and non-conformance issues
- Conduct internal audits to assess compliance with CGMP (Current Good Manufacturing Practices) requirements
- Support project management activities related to quality improvement initiatives
Qualifications:
- Bachelor's degree in Engineering or related field
- Proven experience in Quality Engineering or a similar role
- Strong knowledge of FDA regulations and quality standards (CGMP)
- Experience with fabricating processes and quality inspection techniques
- Familiarity with HACCP (Hazard Analysis Critical Control Point) principles is a plus
- Proficient in using statistical analysis tools for data analysis
- Excellent problem-solving skills with the ability to analyze complex issues
- Strong attention to detail and accuracy
- Effective communication skills, both verbal and written
- Ability to work independently as well as in a team environment
We offer competitive compensation packages including benefits such as medical insurance, retirement plans, paid time off, and opportunities for career growth. If you are a dedicated and experienced Quality Engineer looking for a challenging role in a dynamic organization, we encourage you to apply.
Job Type: Full-time
Pay: $90,000.00 - $115,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- Day shift
Work Location: In person