The Quality Engineer will develop, establish and maintains quality engineering methodologies, systems, and practices which support customer and regulatory requirements.
The candidate must have experience in regulated environment industries such as pharmaceutical, bio-pharmaceutical or medical devices companies.
- Ensures regulatory compliance by completing or reviewing documentation (customer complaints, CAPA system, risk analysis, technical assessments, investigations, validations, manufacturing instructions, data analysis, trends, process monitoring, nonconforming product among others).
- Support the quality system by monitoring, trending and analyzing quality metrics, and reporting to management.
- Conduct and/or document quality audits.
- Drive and implement quality system improvements.
- Approve product, process and quality system changes.
- Provide functional expertise to other support functions on quality related issues.
Strong knowledge in FDA Regulation and GMP’s.
Bachelor’s degree in engineering and 3 years or more related quality experience
Ultimate Solutions Corp is an equal opportunity employer.
- Ensure Regulatory compliance in area of responsibility to cGMP’s.
- Experience in quality system inspection, documentation, auditing, record keeping, metrics and data analysis.
- Experience in quality audits, corrective/preventive actions and investigation of non-conformance.
- Technical Writing experience is preferred.
- Statistical Knowledge and Quality Process Control experience is preferred.
- Fully Bilingual (English/Spanish).