Quality Engineer

Job Title: Quality Engineer
Location: Wyomissing, PA area
Salary: $80k-110k
We are seeking a highly skilled and detail-oriented Quality Engineer to join our dynamic team. The successful candidate will play a crucial role in ensuring the quality and reliability of our products through the implementation of effective quality control processes and procedures. As a Quality Engineer, you will collaborate with cross-functional teams to identify areas for improvement, develop testing strategies, and drive continuous process enhancements to meet or exceed customer expectations.
Job Duties - Develop and implement quality control procedures and processes to ensure compliance with FDA regulations and industry standards.- Conduct quality audits to identify areas for improvement and implement corrective actions.- Collaborate with cross-functional teams to establish and maintain quality assurance and quality control (QA/QC) programs.- Monitor and evaluate product quality throughout the manufacturing process, from raw materials to finished goods.- Perform quality inspections and tests to identify defects or deviations from specifications.- Analyze data and trends to identify root causes of quality issues and develop solutions for process improvement.- Provide guidance and support to production teams to ensure adherence to quality standards.- Participate in project management activities, including the development of project plans, timelines, and deliverables.- Ensure compliance with current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements.
Qualifications - Bachelor's degree in Engineering, Metallurgical, Chemistry or technical discipline- Proven experience in quality engineering or a related role.- Strong knowledge of FDA regulations, cGMP, and HACCP principles.
- Certification as a Quality Enginer preferred
-Advanced Knowledge of ISO9001. IATF16949, ISO13485, AS9100 and/or Nadcap standard- Experience with quality management systems and tools.- Proficient in analyzing data and using statistical methods for quality control purposes.- Excellent project management skills, with the ability to prioritize tasks and meet deadlines.- Strong attention to detail and problem-solving abilities.- Excellent communication skills, both verbal and written.
Note: This job description is intended to provide a general overview of the position. Duties, responsibilities, and qualifications may be adjusted based on the needs of the company.