Quality Engineer - Maplewood, United States - Vital Path

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
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

ASQ Certifications as a Certified Quality Engineer or Certified Quality Auditor
Experience with ISO13485:2016 and 21CFR Title 21 – Part 820 preferred
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
Paid Holidays
401K with company match
Competitive compensation
Opportunities for career growth and advancement
VitalPath is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, work related mental or physical disability, veteran status, sexual orientation, gender identity, or genetic information.

VitalPath participates in E-Verify.

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