FetchJobs.co · 4 hours ago
Senior Quality Engineer
United States
Full-time
Remote
Mid, Senior Level
3+ years expVantive is a vital organ therapy company focused on extending lives and enhancing the dialysis experience through innovative solutions. The Senior Quality Engineer plays a crucial role in maintaining quality systems for medical devices, ensuring compliance with regulatory standards, and collaborating with teams to uphold quality standards.
Information Technology & Services
Responsibilities
Develop and manage the internal audit schedule for Vantive's Twin Cities location, ensuring timely and effective audits across departments
Assist in conducting internal audits for Medical Device R&D and Drug Product R&D organizations, preparing detailed reports and follow-up actions
Coordinate and communicate audit findings through comprehensive internal reports, ensuring transparency and continuous improvement
Host and perform internal audits in collaboration with the Quality Manager, ensuring adherence to quality standards and regulatory requirements
Maintain site compliance with local and global Quality Management System (QMS) procedures, updating documentation as needed
Perform quality functions related to post-market activities, including nonconformance investigations, CAPA management, and trend analysis
Serve as a QMS Subject Matter Expert, providing guidance and training to site personnel on quality requirements and best practices
Assist in preparing for and hosting external audits by regulatory agencies, ensuring readiness and compliance
Review and approve design inputs, outputs, verifications, validations, and design transfers in accordance with QMS standards
Support process and product improvement initiatives through data analysis and collaborative decision-making
Draft, review, and revise local QMS documentation to ensure clarity, accuracy, and compliance with applicable standards
Qualification
Required
Bachelor's Degree in Engineering, Science, or a related field
At least 3 years of relevant experience in the medical device or similarly regulated industry, or 7 or more years of experience in the same field
A minimum of 2 years of experience performing internal or external audits
Demonstrated understanding of Quality Engineering principles, worldwide Quality System standards, and regulatory requirements
Strong analytical, problem-solving, and communication skills
Ability to work independently under deadlines and adapt to changing priorities
Preferred
Formal audit training or certification
Certifications such as CQE or CQA from the American Society for Quality
Six Sigma certification
Experience with risk management techniques
A background in engineering or science disciplines
Assertiveness and experience representing the quality function in R&D activities
Benefits
Medical, dental, and vision coverage starting from day one
Insurance options for basic life, accident, short-term and long-term disability, and business travel accident insurance
Participation in the Aon Pooled Employer Plan ("Aon PEP") 401(k) retirement savings plan
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on tenure
Family and medical leaves
Paid parental leave
Commuting benefits
Employee discounts
Employee Assistance Program (EAP)
Childcare benefits
Company
FetchJobs.co
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase