Lowell Inc.

Document Control Specialist

Document Control Specialist Summary:

Lowell Inc. is looking for a Document Control Specialist to create and maintain all documents necessary to define product configuration and control manufacturing processes that ensure conformance to customer and regulatory requirements. Utilizes Quality Management System Software to retain all documents.

Lowell is the premier partner for the development and production of technologically advanced, implantable medical devices for the cardiovascular, spine, trauma and extremities markets.  We manufacture components and assemblies that save lives and improve quality of life. 

Document Control Specialist Responsibilities:

• Maintain Lowell’s electronic document management system.
• Create and maintain documents for product and service provisions as well as quality management system.
• Develop process for maintaining and retaining all procedural requirements.
• Assist in supporting external audits, coordinating activities, and ensuring timely response to documentation requests for auditors.
• Follow the established procedures and policies needed to meet the demands of document control in a regulated medical device company.
• Design and prepare visual reporting while overseeing and properly maintaining the various forms of data input.
• Control all company documents including controlled documents.
• Work with management and team associates in the continuous improvement initiative at Lowell.
• Administrative support for the Quality Lab and interfaces with the Engineers on the production jobs via M1.

Education/Experience:

• 3 to 5 years of experience in a manufacturing environment required. 
• 5+ years of experience in a document control environment preferred.
• Strong interpersonal skills.
• Advanced knowledge of Microsoft products including Excel, SharePoint, Word and PowerPoint.
• Strong communication, prioritization and organizational skills.
• Ability to work with minimal supervision.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers.
• Proven problem solver who can build consensus and improve team collaboration.
• Experience working in the Medical or other highly regulated industry, specifically ISO 13485:2016 and FDA CFR820.
• Experience with Adobe InDesign.
• Experience working with M1 ERP system or similar.

Benefits:

Lowell offers a competitive compensation and benefits package including Medical, Dental, Vision, Life Insurance, Short Term Disability, 401k Retirement Plan with 3% employer contribution, and Profit-Sharing plan.

If you are a highly motivated individual who takes pride in their work, we would love to hear from you.  Join our team as a Document Control Specialist and contribute to our commitment to excellence in medical device manufacturing. Please submit your resume to Shelly.anderson@lowellinc.com

This description covers the primary purpose and principal duties of the job. It is not designed to be a complete list of all the duties and responsibilities required of this position. Duties, responsibilities, and activities may change at any time with or without notice.