Manpower San Diego · 14 hours ago
Manufacturing / Operations Quality Engineer 2
San Diego, CA
Full-time
Onsite
Mid Level
$35/hr - $44/hrManpower San Diego is seeking a Manufacturing / Operations Quality Engineer 2 responsible for manufacturing and product Quality activities. The role involves supporting day-to-day sustaining activities in a manufacturing environment and requires strong communication and project management skills.
Staffing & Recruiting
Responsibilities
Provide ongoing quality engineering support throughout the product life cycle
Provide support to engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements
Ensures adequacy of non-conformances and QI/CAPA records, investigations, and corrective actions
Support process risk management activities and ensure quality and completeness of validation packages, and change orders
Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
Review verification and validation reports and identify gaps for GMP compliance
Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
Coordinate issue resolution using a risk-based approach
Ensure manufacturing processes and validation programs meet requirements of FDA and ISO
Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis
Collaborate with counterparts and cross-functional teams at other sites
Other activities as assigned
Qualification
Required
Bachelor's degree in an engineering discipline
Exceptional communication skills
Exceptional interpersonal skills
Exceptional project management skills
Provide ongoing quality engineering support throughout the product life cycle
Provide support to engineering and manufacturing functions for validation planning and transfer activities
Ensures adequacy of non-conformances and QI/CAPA records, investigations, and corrective actions
Support process risk management activities and ensure quality and completeness of validation packages, and change orders
Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
Review verification and validation reports and identify gaps for GMP compliance
Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
Coordinate issue resolution using a risk-based approach
Ensure manufacturing processes and validation programs meet requirements of FDA and ISO
Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis
Collaborate with counterparts and cross-functional teams at other sites
Support change management activities, Nonconformances, equipment lifecycle, meeting facilitation and other ad hoc sustaining manufacturing requests
Company
Manpower San Diego
Actively involved in public policy, workplace issues, and economic development.
Founded in 1977
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase