• Perform visual inspections of incoming product shipments in accordance with approved inspection plans and work instructions.
• Review supplier documentation (e.g., Certificates of Conformance, Certificates of
  Analysis, test reports, sterilization documents, and finished goods inspection records) for
  completeness and compliance prior to product acceptance.
• Accurately document inspection results in the Electronic Quality Management System
  (eQMS) and maintain traceability to lot numbers, purchase orders, and inspection
  records.
• General document and record control responsibilities related to product inspections.
• Identify, segregate, and document nonconforming product per the Control of
  Nonconforming Product procedure.
• Maintain and update inspection forms, inspection criteria, and the eQMS inspection
  module as required.
• Perform on-site product testing as needed.
• Notify the Quality Assurance Lead of issues that could impact product compliance,
  processes, or customer satisfaction.
• Notify the Quality Assurance Lead of issues that could impact product compliance,
  processes, or customer satisfaction.
• Assist in analysis of returned products and contribute to root cause investigations,
  Corrective and Preventive Actions (CAPA), and process improvements.
• Support internal audits and regulatory inspections by providing inspection records and
  evidence of compliance.
• Follow Good Documentation Practices (GDP) to maintain accurate, complete, and legible
  quality records.
• Analyze inspection data to identify trends and support product improvement initiatives.

Qualifications:

• High School Diploma or equivalent; technical training or quality certification preferred.
• 1–3 years of experience in product inspection, preferably in a regulated medical device or
  manufacturing environment, preferred.
• Familiarity with ISO 13485:2016 and 21 CFR 820 quality system requirements.
• Proficiency in Microsoft Excel, Outlook, and PowerPoint; experience with electronic
  quality management systems preferred.
• Strong written and verbal communication skills, with excellent attention to detail.
• Ability to lift and transfer up to 25 lbs.

Why MedSource Labs:

At MedSource Labs, we pride ourselves on our commitment to quality and innovation. As a key player in our product development and commercialization efforts, you will be at the forefront of delivering impactful products that make a difference in healthcare. We offer a collaborative, fast-paced work environment where your ideas and contributions are valued, and where your efforts can directly influence the success of our business and the well-being of patients worldwide.

About Us:

MedSource Labs is a premier developer and supplier of innovative, high-quality medical products dedicated to improving patient outcomes across diverse healthcare sectors. Since our founding in 2002, we have been at the forefront of delivering reliable, cost-effective solutions to a broad range of healthcare professionals, including emergency medical providers, hospitals and surgical centers, veterinarians and dental providers, as well as government agencies.

Headquartered in Chanhassen, Minnesota, MedSource Labs is committed to setting the standard in medical product development by blending cutting-edge technology with unparalleled industry expertise. Our goal is to not only meet the evolving needs of the healthcare industry but to exceed expectations by creating products that enhance both clinical outcomes and operational efficiencies.

We take pride in our strong values and collaborative culture. At MedSource Labs, our people are our greatest asset. We actively seek individuals with diverse backgrounds, experiences, and perspectives because we believe that diversity drives innovation. It’s not just about doing the right thing—it’s about fostering an environment where creativity, problem-solving, and teamwork lead to exceptional products and services. We value the unique contributions that every employee brings to the table and understand that their diverse experiences strengthen our company, allowing us to continuously evolve in a competitive market.

Our Culture:

We cultivate a culture of empowerment and collaboration, where employees feel valued and motivated to bring their best ideas forward. By providing opportunities for personal growth and professional development, we ensure that every member of the MedSource Labs team is equipped to contribute to our mission of advancing healthcare globally.