VIVOS Professional Services, LLC ยท 11 hours ago
Senior Quality Analyst/Engineer
Madison, WI
Contract
Onsite
Senior Level
$42/hr - $45/hr
5+ years expVIVOS Professional Services, LLC is seeking a Senior Quality Analyst/Engineer responsible for ensuring compliance and maintaining strong Quality Systems for their Madison facility. The role involves overseeing CAPA, Change Management, investigations, audits, and quality metrics, while supporting quality improvement initiatives and collaborating with various departments to enhance quality culture.
Staffing & Recruiting
Hiring Manager
Praduman J.
Responsibilities
Develop and maintain Quality System processes, including metrics reporting and tracking
Manage CAPA initiation, review, surveillance, and reporting
Facilitate site Quality Management Reviews
Lead and coordinate the site Change Management process
Support and lead root cause analysis through cross-functional teams
Lead Good Documentation Practice (GDP) training and Quality on the Floor activities
Interpret and apply all applicable regulatory requirements
Coordinate and support facility audits by internal and external agencies
Manage data collection and reporting for product recalls
Perform Quality System trending to support FDA and Management reviews
Drive quality culture through site initiatives and procedure improvements
Review and approve procedures, protocols, and reports as required
Documentation filing and management as needed
Support other Quality System functions
May be required to lead personnel within or outside the Quality organization
Qualification
Required
Bachelor's degree (or higher) in a science or technology field preferred
5+ years of Quality Assurance experience in a cGMP-regulated environment (medical device experience preferred)
Strong communication, coaching/mentoring, and presentation skills
Ability to manage change effectively
Self-motivated with strong decision-making abilities
Project management skills with a track record of on-time delivery
Leadership and emotional intelligence
Moderate proficiency in statistics for data trending and interpretation
Proficient in Microsoft Excel, Word, and PowerPoint
Strong technical writing skills
Preferred
Experience with statistical analysis software (e.g., Minitab preferred)
Company
VIVOS Professional Services, LLC
VIVOS Professional Services (a Kellton Company) is a premier professional workforce solutions firm.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase