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VitalPath · 6 days ago
Quality Engineer II
New Hope, MN
Full-time
Onsite
Mid Level
3+ years exp
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Responsibilities
Support engineering, manufacturing, inspection, qualification, and validation of products
Develop and implement quality improvement initiatives with a working knowledge of Quality standards and systems
Assure compliance with Quality Management Systems (QMS), ISO 13485:2016, and customer/regulatory requirements
Support Development activities for transitioning Manufacturing Processes and related documentation
Collaborate with customers and suppliers to resolve quality-related issues
Participate in 3rd party and customer audits
Conduct failure investigations, root-cause analysis, and corrective action implementation
Develop, approve, review, and update controlled documents such as procedures, work instructions, etc.
Train personnel on new or updated QMS documents
Review and approve customer and internal drawings and specifications
Establish and maintain accurate records per QMS requirements
Implement Quality and Inspection support systems
Support the implementation of company-wide systems related to Quality
Perform other duties as assigned
Qualification
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Required
Bachelor’s Degree in engineering or related discipline
3 years of Quality Engineering experience in catheter medical device manufacturing
3 years of experience in support of QMS audits
Experience working in quality systems defined in 21 CFR 820 and ISO 13485
Demonstrated ability to implement, execute, and maintain quality system policies and procedures
Ability to define problems, collect data, establish facts, and draw valid conclusions
Diverse knowledge of inspection and control methods, techniques, and documentation
Ability to interpret and understand drawing specifications, tolerances, procedures for inspection, and the application of sampling plans
Able to sit/stand at a desk for extended periods of time
Preferred
2 years’ experience working with automated inspection systems
Demonstrated experience in software validation
Experience in product development and process design development team environment
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)
Paid Time Off
Sick Time Off
Paid Holidays
401K with company match
Competitive compensation
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
Randall Sword
Chief Executive Officer
Calvin Vang
Chief Technology Officer
Company data provided by crunchbase
