Quality Engineer II

Vital Path 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.

Join Vital Path in Maplewood as a Quality Engineer II!

The Quality Engineer II is primarily responsible for providing technical support to ensure Customer requirements are understood and properly implemented. The Quality Engineer II will work cross‑functionally contributing to Development and Manufacturing, Engineering, Qualification, and Validation activities. Supports Operations, Sales, and Quality by providing effective Non‑conformance processing, Supplier control and Outsourced services integrity, Complaint handling, and related CAPA activities.

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

• Support manufacturing, inspection, qualification, and validation of products.
• Develop and implement quality improvement with working knowledge of Quality standards and systems.
• Assure compliance of the Quality Management System (QMS), ISO 13485:2016, and customer/regulatory requirements.
• Work with customers and suppliers to resolve quality related issues.
• Support and participate in 3rd Party and customer audits, as needed.
• Work cross‑functionally on failure investigations, root‑cause analysis, and corrective action implementation.
• 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.
• Develop and implement systems for Quality and Inspection support.
• Support implementation of overall company systems that relates to Quality.
• Other duties as assigned.

• Bachelor's Degree in Engineering or related discipline.
• 3 years of experience in medical device manufacturing, in a quality role.
• 3 years of experience in support of QMS audits.
• Experience with ISO 13485:2016 or related ISO standard.
• Able to sit/stand at a desk for extended periods of time.

• Demonstrated experience in software validation.
• Experience in the manufacturing of catheters.
• 2 years experience working with automated inspection systems.

• The salary range for this position is $69,300 - $88,000. The posted salary range complies with federal and local regulations and may vary based on factors such as market conditions, level of experience and training, education, certifications, as well as internal and external equity.
• This position is eligible to earn an annual performance bonus based on meeting Vital Path's bonus performance plan.

• 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.

Vital Path 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. Vital Path participates in E‑Verify.

This position is currently accepting applications.