Quality Lead Inspector

Join Vital Path in Maplewood as a Quality Lead Inspector - 1st shift!

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.

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 Vital Path with a strong vision in mind - We are one Vital Path.

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 Vital Path 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!

The Quality Lead Inspector is responsible for leading quality systems and manufacturing quality activities to ensure medical devices are produced in compliance with ISO 13485 and applicable international standards. This role partners closely with Manufacturing, Engineering, and Quality to maintain compliance, drive continuous improvement, and ensure product safety and effectiveness.

• This position requires the employee to be onsite at our Vital Path Maplewood, MN location.
• Shift/
  
  Schedule:
  
  First shift - Monday‑Thursday 4:00am‑2:30pm (4x10 hour schedule)
• Vital Path does not offer relocation assistance for this position.

• Serve as the quality representative for manufacturing operations, ensuring compliance with procedures, work instructions, and regulatory requirements.
• Provide guidance to production operators and quality inspectors for in‑process and final inspection best practices and other shop floor related duties.
• Take initiative to manage work for the team and identify continuous improvement initiatives.
• Handle and use typical quality inspection equipment including microscope, video measuring system, toolmakers scope, force testers, pin gages, calipers, rules, micrometer, and other tools or methods.
• Ability to read and interpret documents such as policies, procedures, blueprint drawings, and other materials related to the position.
• Support investigations and CAPA activities related to nonconformances, deviations, customer complaints, and audit findings.
• Manage nonconforming material processes, MRB activities, and disposition decisions.
• Support process validation, equipment qualification (IQ/OQ/PQ), and change control activities.
• Review and approve manufacturing, production, and quality documentation including DHRs, SOPs, control plans, travelers, and inspection records.
• Support internal audits and support inspections, notified body audits, and customer audits.
• Support Engineering and Manufacturing on NPI and design transfer to ensure quality readiness.
• Support supplier quality activities including incoming inspection issues.
• Train and coach employees on GMP, GDP, quality procedures, and regulatory compliance requirements.
• Promote a culture of compliance, and product quality to ensure safety.
• Additional responsibilities as determined by the supervisor.

• High School diploma or GED or related work experience and/or training
• 4+ years of medical device experience
• 5-7 years in a quality role
• Must exhibit a willingness to work in teams and promote teamwork among other employees
• Excellent attention to detail, including spotting products or material nonconformity
• Highly focused and detailed oriented
• Blueprint reading and interpretation
• Proficient in reading, writing, and speaking English
• Genera…