Position Summary

Manage document control process for new and revised procedures within the QMS. Maintain training matrix and ensure training assignments are distributed, completed, and maintained in accordance with the regulatory requirements. Partner with Quality, Regulatory, and other cross-functional departments to support timely document reviews, approvals, and training completion. Identify and lead improvements to QMS, document control, and training processes and systems to increase efficiency and compliance.

Essential Duties and Responsibilities

• Review and obtain approval of quality system documentation (quality manual, procedures, work instructions, forms, corporate operating procedures and policies), development of various quality system documentation and maintenance of documentation files both electronic and hardcopy. Administer document numbering, revision history, and approval workflows for controlled documents within the QMS, in accordance with ISO 13485, 21 CFR 820, and EU MDR requirements.
• Assist in preparation of regulatory submissions to the national and international government agencies, e.g. US FDA and Health Canada.
• Documentation file maintenance including Quality System documentation, Departmental files, archived files, reference material files, etc. in both hardcopy and/or electronic files.
• Support the change control process for revisions to controlled documents; track change requests through review, approval, and implementation to ensure timely closure.
• Conduct periodic reviews and audits of controlled documents to verify accuracy, completeness, and continued regulatory compliance; support document control metrics and reporting.
• Identify, recommend, and lead improvements to document control and QMS processes and systems, such as streamlining review/approval workflows or enhancing the eQMS platform.
• Manage corporate training matrix and revise as needed.
• Manage distribution of training material, maintain training files and ensure compliance with regulatory requirements. Track training assignment completion, generate compliance metrics and reports for management, and follow up on past-due assignments.
• Partner with department managers to identify training needs arising from procedure revisions, new hires, and audit findings.
• Assist in on-boarding of new hires.
• Assist management with internal and external audits.
• Assist in the development and distribution of annual management review.
• Special projects as needed.

Job Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Qualifications

• Bachelor’s degree in related field or comparable experience working in the medical device industry, Quality Assurance, Regulatory Affairs, Compliance or Development.
• Must demonstrate the ability to learn and understand technical concepts as well as national and international government procedures, practices, regulations, and guidelines (e.g. US FDA, EU MDR, and Health Canada).
• Excellent technical writing skills.
• Proficient in Adobe Acrobat, Microsoft Office (Word, Excel, PowerPoint, Access) and Sharepoint. Experience with an electronic Quality Management System (eQMS) or document control software preferred.
• Experience developing, implementing, and/or maintaining a Quality Management System (QMS), with working knowledge of ISO 13485, 21 CFR 820, and EU MDR document control requirements strongly preferred.
• Experience coordinating or administering corporate training programs, including use of a Learning Management System (LMS), preferred.
• Proficient in Adobe Acrobat, Microsoft Office (Word, Excel, PowerPoint, Access), and Sharepoint. Experience with electronic document control/QMS software and Learning Management Systems (LMS) preferred.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Experience

• Experience working in the medical device industry, Quality Assurance, Regulatory Affairs, Compliance or Development preferred.
• Experience managing a QMS, including developing, implementing, and maintaining QMS documentation, with a demonstrated ability to identify and lead improvements to document control and training processes and systems, preferred.

Dornier MedTech offers a full benefits package including medical, dental, and vision coverage, company-paid life and disability insurance, 401(k) match, generous PPL, 12 paid holidays, and education reimbursement, because we invest in our people as much as our technology.