Select Source International · 19 hours ago
Quality Engineer II
San Diego, CA, US
Full-time
Onsite
Entry, Mid Level
$40/hr - $45/hr
2+ years expSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions. The Quality Engineer II is responsible for validation of analytical methods, production processes, and equipment qualifications, as well as generating and maintaining process FMEA and supporting regulatory submissions.
ConsultingFinancial ServicesInformation Technology
Responsibilities
Provides Quality leadership to new product development teams in the areas of validation, design transfer, risk management and specification development
Author master validation plans and reports
Author and execute validation protocols and reports (Analytical Methods, Equipment, Facilities/Utilities, Raw Materials, Process, and Cleaning)
Review the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities)
Determine validation strategy based on acceptable risk-based approach
Lead cross-functional team to write PFMEAs under limited supervision
Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV)
Assist in maintaining validation records
Support cross-functional teams during New Product Introduction (NPI) and Sustaining projects
Review regulatory submissions and/or notifications under limited supervision
Propose improvement projects with supporting data, flowcharts, etc
Assist in developing/updating departmental procedures and other controlled documents
Evaluate adequacy of specifications for new or modified process designs under limited supervision
Lead department and cross-department projects under limited supervision. Determine QE deliverables and assist in generating project timelines
Participate in process design reviews
Assist QE management in Material Review Board (MRB) and Production Response Team (PRT) meetings
Participate in department process improvements goal(s)
Assist in development, maintenance, and reporting of department metrics
Provides management with status updates on assigned responsibilities, goals and escalate issues in a timely fashion
Qualification
Required
Bachelor's degree in Science or Engineering
MINIMUM of 2 years of experience in a diagnostic, medical device, biotech or pharmaceutical company
Proficient in validation methods and evaluation criteria
Experience with process validation, analytical method validation, cleaning validation, facility/utility and equipment qualifications
Experience with change control process and documentation requirements
Experience with electronic document management systems
Understanding of statistics, SPC and acceptance sampling
Experience with risk analysis and PFMEA
Working knowledge of CDRH, CBER and ISO regulations (e.g., 21 CFR Part 820, ISO 13485, ISO 14971)
Working knowledge of 21 CFR Part 11
MUST HAVE Validation experience and Quality experience
Preferred
Validation experience in custom equipment
Design validation protocols and statistical sampling
Good at problem solving
Working cross functionally with other departments
Organized- able to manage multiple projects and tasks
Communication- keeping every department in the project aware of the project needs
Company
Select Source International
Select Source International (SSI) is an award-winning global leader in Consulting and Staff Augmentation, helping businesses thrive across IT, Healthcare, Finance & Accounting, Human Resources, Engineering, Energy & Utilities, Manufacturing, Administrative, Operations & Logistics, and more.
501-1000 employees
H1B Sponsorship
Select Source International 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
2025 (2)
2024 (2)
2023 (3)
2022 (2)
2020 (4)
Funding
Current Stage
Late StageCompany data provided by crunchbase