VitalPath · 5 hours ago
Quality Engineer II
Cokato, MN
Full-time
Onsite
Mid Level
$69K/yr - $87K/yr
3+ years expVitalPath is a trusted contract manufacturing partner specializing in high-quality complex catheter solutions. The Quality Engineer II is responsible for providing technical support to ensure customer requirements are met, working cross-functionally to support development, manufacturing, and quality assurance activities.
Medical Device
Responsibilities
Support manufacturing, inspection, qualification, and validation of products
Develop and implement quality improvement with working knowledge of Quality standards and systems
Assures compliance of the Quality Management System (QMS), ISO 13485:2016, and customer/regulatory requirements
Works with customers and suppliers to resolve quality related issues
Support and participate in 3rd Party and customer audits, as needed
Work cross-functionally on failure investigations, root-cause analysis, and corrective action implementation
Develop, approve, review, and update-controlled documents such as Procedures, Manufacturing Procedures, Work Instructions, Forms, etc
Train personnel, as needed, on new or updated QMS documents
Review and approve customer and internal drawings and specifications
Ensure that records are established, accurate and maintained per QMS requirements
Develop and implement systems for Quality and Inspection support
Support implementation of overall company systems that relates to Quality
Other duties as assigned
Qualification
Required
Bachelor's Degree in Engineering or related discipline
3 years of experience in a quality role in a medical device manufacturing environment
3 years of experience in support of QMS audits
Experience with ISO 13485:2016 or related ISO standard
Able to sit/stand for extended periods of time
Preferred
Demonstrated experience in software validation
Experience in manufacturing of catheters
2 years of experience working with automated inspection systems
Benefits
Comprehensive, Low Cost Health and Dental Insurance Plans Available
Vision Insurance
Health Savings Account with company contribution
Short and Long Term Disability
Supplemental insurances (short term disability, AD&D, life insurance, and more)
Parental Leave
Paid Time Off
Minnesota Earned Sick & Safe Time
Paid Holidays
401K with company match
Opportunities for career growth and advancement
Company
VitalPath
VitalPath is a medical & catheter and medical design company.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Nicole Ramus
Vice President, Global Sales
Recent News
BioWorld Financial Watch
2025-03-05
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