Quality Document Control Specialist

At MedSource Labs, we are committed to improving patient outcomes, providing our customers with high-quality products at cost-effective prices. We are a manufacturer of medical products that are sold throughout the world. We are seeking a Document Control Specialist to support our Quality Team. The Document Control Specialist is responsible for ensuring the accuracy, accessibility, and correct filing of all documentation within our organization. The Document Control Specialist will collaborate closely with all departments to establish and maintain efficient document control processes in adherence to regulatory and internal requirements.

Duties and Responsibilities:

Works with all departments to ensure compliance with regulatory standards, third-party certification standards, and internal policies. Data entry, data management, and report generation.

Document Management:

Transitioning all paper files into the eQMS. Reviewing documents and records. Oversee the review, approval, and maintenance of controlled documents, including but not limited to standard operating procedures, work instructions, guidance documents, specifications, and forms. Follow internal guidelines on the identification of documentation within the eQMS.

Document Retrieval and Distribution:

Develop and maintain documentation within our electronic quality management system (eQMS) to ensure efficient document retrieval and distribution. Coordinate document retrieval requests from internal stakeholders and provide support for document-related inquiries.

Continuous Improvement:

Identify opportunities for process improvements within the document control function and contribute to the implementation of best practices. Participate in cross-functional teams and initiatives aimed at enhancing document management processes and ensuring organizational efficiency. Perform inspections of incoming product shipments and the approval of inspection documentation as needed. Notifies supervisor of issues that could affect the product, processes and/or any relationship with customers.

Qualifications:

High School Diploma or Equivalent Experience 1-3 years' experience preferred. Basic understanding of Excel, Microsoft Outlook, and PowerPoint. Strong written and verbal communication skills with a focus on attention to detail. Knowledge of the medical device industry and the FDA and ISO regulatory requirements preferred. Strong understanding of regulatory requirements governing document control, including FDA regulations (21 CFR Part 820) and ISO standards (ISO 13485) preferred. Prior experience in document control within the medical device or pharmaceutical industry is highly desirable. Proficiency in document management systems and software tools Excellent organizational skills with a keen eye for detail and accuracy. 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.

Pay:

$19.00 - $25.00 per hour

Benefits:

Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Parental leave Referral program Retirement plan Vision insurance

Work Location:

In person