Quality Engineer-(Medical Device)

ZipRecruiter; San Jose (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Quality Assurance professional to ensure product and process validation compliant with FDA regulations. The role involves supporting quality systems, conducting oversight of validation activities, and ensuring adherence to cGMP standards across product lifecycles.

Qualifications

• 2+ years of Quality/cGMP experience in the pharmaceutical industry.
• Knowledge of 21CFR Part 11, Electronic Records and Signatures, and data integrity.
• Experience in aseptic process simulations and regulatory inspections.

Responsibilities

• Support quality systems to ensure compliance with cGMP requirements.
• Collaborate with teams to provide quality oversight for validation activities.
• Maintain knowledge of regulatory requirements related to quality.

Skills

Quality Risk Management

Technical expertise in sterile pharmaceutical isolator technology

Cleaning validation

Process validation

LIMS systems

Education

Bachelor’s degree in a scientific discipline

Job description

Job Description

Qualifications

• Bachelor’s degree in a scientific discipline with 2+ years of Quality/cGMP experience in the pharmaceutical industry
• Experience in process and cleaning validation, LIMS systems, Aseptic Process Simulations, and Quality Risk Management
• Knowledge of 21CFR Part 11, Electronic Records and Signatures, and data integrity is required
• Participation in and leading activities to support regulatory agency inspections is required
• Technical expertise in sterile pharmaceutical isolator technology, combination products, and medical devices

Responsibilities

• Support quality systems and oversight to ensure product process validation, cleaning validation, Quality Risk Management, and quality laboratory systems meet cGMP and compliance requirements
• Review and/or approve policies, procedures, reports, and other records necessary for quality oversight to ensure FDA requirements are met
• Collaborate with validation and engineering teams to provide Quality oversight for validation and qualification activities, ensuring work is performed in a compliant and controlled manner
• Participate in Quality Risk Management and analysis
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to provide expert advice and technical support on quality-related matters
• Support product process transfers, including validation, from and/or to other manufacturing sites
• Assist with activities related to product introduction to the site
• Support aseptic process simulations
• Support quality processes and systems across the product lifecycle, including change control, CAPA, deviations and investigations, laboratory control, Annual Product Quality Review (APQR), and management notifications
• Provide quality review and support for laboratory method validation/verification and Laboratory Information Management System (LIMS)

Thanks

Suchi

[e-mail]

Company Description

Vastek Inc is managed by a group of dedicated professionals with extensive experience in Healthcare, IT consulting, and staffing. We are a certified minority-owned small business headquartered in San Diego, with coverage across the United States, Canada, Mexico, Italy, and India. We specialize in Engineering, Validation, Regulatory, IT, and NON-IT areas, primarily focused on Pharmaceutical, Life Sciences, and Medical Device companies.