Quality Lead Inspector

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

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 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.

Work Location/Schedule

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

Responsibilities

• 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.

Required Qualifications

• 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
• General computer skills with the Microsoft Office suite
• Use verbal and written communication to exchange information required to complete essential duties and responsibilities
• Demonstrated ability to interpret dimensional requirements on drawing and specifications
• Documentation review for GDP compliance
• Ability to influence others to follow rules and regulations
• Ability to use measuring devices like gauges, meters, calipers, and computers
• May require extended hours during audits, inspections, or critical production needs.
• Occasional travel to multiple sites.

Preferred Qualifications

• ISO 13485 knowledge and/or Certification
• eQMS and ERP experience
• Experience with cleanroom manufacturing environments.

Compensation Package

• The hourly range for this position is $29 - $39.13 . The posted hourly 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 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, MN paid family & medical leave, and more)
• Parental Leave
• Paid Time Off
• Minnesota Earned Sick & Safe Time
• Paid Holidays
• 401K with company match
• Opportunities for career growth and advancement