inSync Staffing ยท 16 hours ago
Senior Quality Analyst/Engineer
Madison, WI
Full-time
Onsite
Senior Level
$45/hr - $48.50/hr
5+ years expinSync Staffing is seeking a Senior Quality Analyst/Engineer to maintain and improve Quality System processes at their Madison facility. The role involves ensuring compliance with regulatory requirements and driving continuous improvement across various quality management activities.
B2BDeliveryHuman ResourcesInformation TechnologyStaffing Agency
Responsibilities
Develop, maintain, and improve Quality System processes, including metrics tracking and reporting
Manage CAPA initiation, review, monitoring, and reporting activities
Facilitate and lead Quality Management Reviews at the site level
Lead and coordinate the site Change Management process
Support and lead root cause analyses through cross-functional collaboration
Deliver Good Documentation Practice training and coordinate Quality on the Floor activities
Interpret and apply applicable regulatory and cGMP requirements
Coordinate and support internal and external facility audits
Manage data collection and reporting for product recalls when required
Perform Quality System trending to support FDA inspections and management reviews
Drive quality culture initiatives and improve procedures to align with regulatory expectations
Review and approve procedures, protocols, reports, and related documentation
File and manage quality documentation as needed
Support additional Quality System functions
Lead internal and external personnel in support of business needs when required
Qualification
Required
5+ years of Quality Assurance experience in a cGMP-compliant environment
Strong communication, coaching, mentoring, and presentation skills
Ability to manage change and work independently
Sound decision-making and problem-solving capabilities
Project management skills with a focus on on-time delivery
Demonstrated leadership skills and emotional intelligence
Moderate proficiency in statistical data analysis and interpretation
Proficiency in Microsoft Office, especially Excel, Word, and PowerPoint
Strong technical writing skills
Working knowledge of statistical analysis tools such as Minitab or equivalent
Preferred
Bachelor's degree or higher in a science or technology-related field preferred
Medical devices experience preferred
Benefits
401(k)
Dental insurance
Health insurance
Vision insurance
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