Quality Engineer

• Bachelor’s Degree in Engineering and 5 years of experience in the review and approval of life cycle validation documentation in the regulated industry.
• Bilingual: Spanish and English
• Soft Skills: Attention to detail, organization, and writing skills
• Shift: Administrative, and according to the business
• Experience:

• Quality assurance focused on reviewing validation cycle documentation, quality systems, procedures, change control, and design control.

• Quality processes, including change assessments, process validations, and software validations, as well as experience in sterile packaging and labeling systems.
• Conduct and manage change assessments and process validations to ensure compliance with regulatory standards and company policies.
• Perform ESQ (Engineering Software Quality) and software validations to maintain high-quality software performance and reliability.
• Oversee sterile packaging processes, including final packing and labeling, ensuring adherence to safety and quality standards.
• Conduct inspections of labeling systems and processes to guarantee accuracy and compliance.
• Collaborate with cross-functional teams to identify and address quality issues, implementing corrective actions as needed.
• Utilize and maintain knowledge of systems such as Windchill, CAPA, MES, and BMRAM for effective quality management and documentation.

Flexible & Integrated Technical Services