Medical Device Quality Inspector

Job Description

Job Description

At MedSource Labs, we are committed to improving patient outcomes by delivering high-quality, cost-effective medical products to healthcare providers worldwide. As a global manufacturer and distributor, our products are trusted by healthcare professionals around the world. We maintain a robust Quality Management System (QMS) designed to meet and exceed the requirements of ISO 13485 : 2016 and 21 CFR 820.

We are seeking a Quality Inspector to support our Quality Assurance team in ensuring that products meet defined specifications, are properly documented, and comply with applicable regulatory standards.

Position Summary

The Quality Inspector is responsible for performing and documenting inspections of incoming products, verifying supplier documentation, and supporting internal processes related to product quality and regulatory compliance. This position plays a key role in ensuring that products are released only when they meet all requirements, and that inspection activities are conducted and recorded according to established document and record control procedures and Good Documentation Practices (GDP).

Essential Duties and Responsibilities

• 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.
• 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

Compliance & Quality Commitment

All employees are expected to follow established quality policies, procedures, and regulatory requirements, including adherence to ISO 13485 : 2016 and 21 CFR 820, and to actively support a culture of continuous improvement.

About Us

MedSource Labs is a leading medical product developer and supplier specializing in high-quality products and innovative medical product development. By delivering top-quality products and solutions at cost-effective prices, MedSource Labs has been helping improve patient outcomes since 2002. The privately held company, headquartered in Chanhassen, Minnesota, serves health care professionals including emergency medical providers, hospitals and surgical centers, veterinarian and dental providers, and government agencies.

We hire great people from a wide variety of backgrounds, not just because it's the right thing to do, but because it makes our company stronger. We value our employees; embrace their qualities and the experiences they bring with them.

Company Description

MedSource Labs is a leading medical product developer and supplier specializing in high-quality products and innovative medical product development. By delivering top-quality products and solutions at cost-effective prices, MedSource Labs has been helping improve patient outcomes since 2002. The privately held company, headquartered in Chanhassen, Minnesota, serves health care professionals including emergency medical providers, hospitals and surgical centers, veterinarian and dental providers, and government agencies.

Company Description

MedSource Labs is a leading medical product developer and supplier specializing in high-quality products and innovative medical product development. By delivering top-quality products and solutions at cost-effective prices, MedSource Labs has been helping improve patient outcomes since 2002. The privately held company, headquartered in Chanhassen, Minnesota, serves health care professionals including emergency medical providers, hospitals and surgical centers, veterinarian and dental providers, and government agencies.