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
• Other duties as assigned

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
• Sick 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.