Quality Engineer I

About VitalPath

VitalPath is a trusted contract manufacturing partner that delivers high-quality complex catheter solutions around the world that save lives and restore patient health and vital function. We strive to treat every product we design and manufacture to the highest level of quality and awareness that these products are going to be used inside of a patient, possibly even our own family members. Our employees impassioned hard work and dedication are at the core of our success. Every function within our organization plays a crucial role in our mission and is deeply valued for its contribution to achieving our shared goals of quality, innovation, continuous improvement, and operational excellence. As a fast-growing organization, we bring harmony and standardization across VitalPath with a strong vision in mind - We are one VitalPath. We embrace our diversity, celebrate each others success, support one another through change, and continue to grow as a high-performing organization. We aim to shape our corporate culture to enhance team member engagement, skills, and productivity so that VitalPath is an employer of choice. If you're ready to contribute to groundbreaking medical advancements in a collaborative, fast paced environment, we invite you to apply and be part of our growth!

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.

Work Location/Schedule

This position requires the employee to be onsite at our VitalPath Maplewood, MN location. VitalPath does not offer relocation assistance for this position.

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 inhouse 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.

Required Qualifications

• A Bachelor's Degree in engineering or related discipline and some knowledge of a quality-based system.
• Ability to problem solve and make independent decisions.
• Knowledge in word processing software and spreadsheets.
• Good communication abilities, confident disposition and a team player.
• Experience as quality professional in a regulated industry.
• Ability to sit for long periods of time.
• Ability to lift 25+ lbs.

Preferred Qualifications

• Experience with ISO13485:2016 and 21CRF Title 21 Part 820 preferred.
• ASQ Certification as a Certified Quality Engineer or Certified Quality Auditor.

Compensation Package

The salary range for this position is $57,752 – $77,000. This position is eligible to earn an annual performance bonus based on meeting VitalPath's bonus performance plan.

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)
• Parental Leave
• Paid Time Off
• Minnesota Earned Sick & Safe Time
• Paid Holidays
• 401K with company match
• Opportunities for career growth and advancement