Medical Device QA Inspector - Onsite, San Diego

ACTalent; San Diego (CA); Presencial; USD 32.000 - 37.000; Jornada completa

Descripción de la vacante

Actalent in San Diego is seeking a dedicated Quality Assurance Technician to support lot-release and manufacturing quality activities in a regulated medical device environment. This onsite role focuses on ensuring products meet quality standards, documentation requirements, and acceptance criteria.

Responsibilities include in-process and final inspections, record review, GMP compliance, audits, nonconforming material handling, and cross-functional collaboration with Quality, Manufacturing,

Formación

• High school diploma or equivalent required.
• Approximately 2 to 3 years of relevant quality, inspection, or manufacturing experience preferred.
• Experience with Good Documentation Practices and GMP.
• Experience with quality inspection, manufacturing documentation, and quality processes.
• Familiarity with NCMRs or nonconforming material processes.
• Strong organizational skills and attention to detail.
• Proficiency with Microsoft Word and Excel.
• Ability to make sound decisions regarding quality issues and requirements.
• Ability to distinguish between specified colors and pass an annual color vision test.

Responsabilidades

• Perform in-process and final product inspection and documentation review.
• Review records for accuracy, completeness, signatures, dates, and adherence to Good Documentation Practices.
• Ensure documentation complies with current Good Manufacturing Practices.
• Conduct in-process manufacturing quality audits.
• Support nonconforming material and NCMR activities.
• Perform product inspection and testing for clinical products.
• Review shipping documentation for order accuracy.
• Generate reports and graphs using Microsoft Word and Excel.
• Work cross-functionally with Quality, Manufacturing, Operations, Engineering, and R&D.
• Assist with training and help identify and resolve quality-related issues.

Conocimientos

Quality inspection

Good Documentation Practices

Color vision

Microsoft Word

Microsoft Excel

Educación

High school diploma or equivalent

Herramientas

Microsoft Word

Microsoft Excel

Descripción del empleo

Actalent in San Diego is seeking a dedicated Quality Assurance Technician to support lot-release and manufacturing quality activities in a regulated medical device environment. This onsite role focuses on ensuring products meet quality standards, documentation requirements, and acceptance criteria.

Responsibilities include in-process and final inspections, record review, GMP compliance, audits, nonconforming material handling, and cross-functional collaboration with Quality, Manufacturing,