inSync Staffing · 12 hours ago
Quality Engineer
San Diego, CA
Contract
Onsite
Mid Level
$35.50/hr - $44.25/hr
4+ years expinSync Staffing is seeking a Quality Engineer to support manufacturing and product quality activities within their Mfg/Ops Quality organization. The role involves coordinating day-to-day sustaining activities, continuous improvement, and quality oversight in a manufacturing environment.
B2BDeliveryHuman ResourcesInformation TechnologyStaffing Agency
Hiring Manager
Becca Kamarad
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
Exceptional communication skills
Exceptional interpersonal skills
Project management skills
Experience in manufacturing and product Quality activities
Ability to support day to day sustaining activities in a manufacturing environment
Direct interaction with Manufacturing and Process Engineering groups
Support for manufacturing sustaining activities
Continuous improvement experience
Manufacturing capacity expansion experience
Quality oversight for more than one manufacturing area
Support for change management activities
Experience with Nonconformances, equipment lifecycle, and meeting facilitation
Ongoing quality engineering support throughout the product life cycle
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 for process risk management activities
Ensure quality and completeness of validation packages and change orders
Familiarity with applicable technology for 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 to improve product and process
Develop recommendations based on data analysis
Collaborate with counterparts and cross-functional teams at other sites
Benefits
Health insurance
Health savings account
Dental insurance
Vision insurance
Flexible spending accounts
Life insurance
Retirement plan
Company
inSync Staffing
inSync Staffing is a staffing and recruiting company providing staff augmentation services.
501-1000 employees
H1B Sponsorship
inSync Staffing has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
Funding
Current Stage
Late StageCompany data provided by crunchbase