Quality Systems & Document Control Specialist

Job Description

Job Description

At MedSource Labs, we are dedicated to improving patient outcomes through innovative, high-quality medical products. We are seeking a detail-oriented and proactive Quality Systems & Document Control Specialist to play a critical role in maintaining and improving our Quality Management System (QMS).

In this role, you will oversee the management, accuracy, and accessibility of controlled documentation within our electronic Quality Management System (eQMS). You will collaborate across departments to ensure compliance with FDA regulations, ISO standards, and internal quality requirements while helping drive continuous improvement initiatives that support operational excellence and regulatory readiness.

This is an excellent opportunity for someone who enjoys organization, problem-solving, process improvement, and working in a regulated healthcare environment. You'll gain valuable experience in FDA-regulated quality systems and ISO 13485 compliance while collaborating across Product Development, Operations, Supply Chain, and Quality. At MedSource Labs, your contributions are visible, valued, and make a real impact.

Duties and Responsibilities:

Quality Systems & Document Control

• Manage the lifecycle of controlled documents within the eQMS, including creation, review, approval, revision, distribution, and archival.
• Ensure all quality documentation complies with FDA, ISO 13485, and internal quality system requirements.
• Support the migration and digitization of legacy paper-based documentation into the eQMS.
• Maintain document numbering, revision control, and retention practices.
• Conduct routine audits of documentation to ensure accuracy, completeness, and compliance.

Cross-Functional Collaboration

• Partner with teams across Operations, Product Development, Supply Chain, Regulatory Affairs, and Quality to support document control activities.
• Serve as a resource for document-related questions and training.
• Coordinate document retrieval requests and maintain efficient access to quality records.

Data Management & Reporting

• Maintain quality system data and records.
• Generate reports and metrics to support quality initiatives and management review activities.
• Assist with audits, inspections, and regulatory documentation requests.

Continuous Improvement

• Identify opportunities to streamline document control and quality system processes.
• Support implementation of best practices that improve efficiency, compliance, and data integrity.
• Participate in cross-functional quality and operational improvement projects.

Additional Quality Support

• Assist with incoming product inspections and review of inspection documentation as needed.
• Escalate quality or compliance concerns that could impact products, processes, or customer satisfaction.

Qualifications:

• High School Diploma or Equivalent Experience.
• 1–3 years of experience in document control, quality systems, compliance, or a related administrative role.
• Strong attention to detail and organizational skills.
• Proficiency with Microsoft Office Suite, particularly Excel and Outlook.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Experience in the medical device, pharmaceutical, healthcare, or other regulated industry.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
• Experience working with electronic Quality Management Systems (eQMS) or document management platforms.
• Familiarity with audits, quality records, and regulatory compliance processes.

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.

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.