Quality Engineer

at  VitalPath

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+ lb

• 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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