General

Job Listing

Number of Positions: 1
Job Listing
Job ID: 14040999
 
Job Location:
 

 
How to Apply:
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Job Title:Quality Engineer
Work Type:Work Days: Weekdays, Work Vary: No , Shift: First (Day), Hours Per Week: 40, Work Type: Regular
 
Salary Offered:Unspecified
Benefits:401(k) or other retirement, Dental Insurance, Health Insurance, Holidays, Sick Leave or PTO, Vacation or PTO, Vision Plan
 
Physical Required:Unspecified
Drug Testing Required:Unspecified
Education Required:
Experience Required:Unspecified
 
Required Skills:
Requirements
Bachelor’s Degree in Engineering or related discipline and some knowledge of a quality-based system
1+ years experience as a quality professional in a regulated medical device industry
Ability to problem solve and make independent decisions
Knowledge in word processing software and spreadsheets
Good communication abilities, confident disposition and a team player
Ability to sit for long periods of time
Ability to lift 25+ lbs
Preferred Skills:
Preferred
ASQ Certifications as a Certified Quality Engineer or Certified Quality Auditor
Experience with ISO13485:2016 and 21CFR Title 21 – Part 820 preferred
 
Job Description:
Join VitalPath in Maplewood as a Quality Engineer!

About VitalPath
VitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function. We’re excited about this important work and bring vital energy to our customer partnerships. In our growing organization it’s important that we continue to offer a small-company, family-oriented environment with competitive pay and benefits. If you want to make a difference in people’s lives and be a part of a friendly, fun place to work with people that value diversity, come join our team!

About the Position
The Quality Engineer will be part of the Quality team which assures quality practices and works with customers on their quality needs.

Responsibilities

Support manufacturing, inspection, qualification, and validation of products
Develop and implement quality improvement with working knowledge of Quality standards and systems
Enforces Quality Management system (QMS), ISO 13485:2016, and customer/regulatory requirements
Works with customers and suppliers to resolve quality related issues
Perform internal quality audits and participate in registrar and customer audits, as needed
Conduct failure investigations, root-cause analysis, and corrective action implementation
Work cross functionally with other in-hours departments & contract manufacturers
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

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