Document Coordinator - Drucker Diagnostics
Philipsburg, PA 16866
About the Job
General Summary:
The Document Coordinator will manage and oversee the documentation processes related to the development, manufacturing, and regulatory compliance of medical devices. This role is critical in ensuring that all documents are accurate, up-to-date, and compliant with industry standards and regulations.
Essential Duties and Responsibilities:
None
Qualifications:
Language Skills:
Excellent written and verbal communication skills.
Computer Skills:
Office environment
Travel Requirements:
Minimal
Dedication to the Quality System (Required)
Our objective is to provide a system that promptly detects non-conformances and provides timely and effective control and corrective actions. This Quality System establishes an effective means of assuring product quality. Our policy is to provide full compliance with the Quality System throughout all facets of contract performance and the order fulfillment process. This ensures that all of our products and services meet or exceed the expected company standards as well as those of our customers and the ISO 13485 International Standard, CMDCAS, FDA, and MDD regulations. We operate the Quality System as an overall management system for all products. Our approach to quality is based on the premise that we can achieve product quality and effective cost control by concentrating on the integrity of processes and preventative measures rather than after the fact detection.
The Document Coordinator will manage and oversee the documentation processes related to the development, manufacturing, and regulatory compliance of medical devices. This role is critical in ensuring that all documents are accurate, up-to-date, and compliant with industry standards and regulations.
Essential Duties and Responsibilities:
- Organize, maintain, and archive all documents which require proper control in an ISO-13485 compliant Quality Management System.
- Ensure all documentation complies with ISO 13485, FDA regulations, and other relevant standards.
- Manage version control for documents, ensuring that the most current documents are accessible and obsolete versions are appropriately archived.
- Coordinate the review and approval process for all documents, ensuring timely completion and adherence to internal policies.
- Work closely with engineering, quality assurance, regulatory affairs, and manufacturing teams to gather necessary documentation and ensure consistency.
- Identify opportunities for improving document management processes and implement best practices.
- Audit controlled documents, track and report on document review progress.
- Manage Periodic Document Review program.
- Manage the organization’s Internal Audit Program.
- Update controlled forms and procedures as needed.
- Assist with the development, implementation, management, and administration of the Quality Management System electronic document management platform.
- Work with subject matter experts on technical subjects in a positive, collaborative manner to prepare controlled documents which conform to defined formats.
- Review and proofread documents for consistency of document format and system concerns.
- Effectively follow SOPs, policies, and QSRs. Provide support for the Quality System during audits, actively participate in department activities.
- Adhere to and enforce policies and procedures related to document control.
- Establish and maintain Master Device Records, Design History Files, and Device History Files.
- Maintain Federal, State and Local license renewals.
- Administrative ownership of digital signature platform.
- Position relevant projects as assigned.
- Other administrative duties as requested by immediate supervisor.
None
Qualifications:
- Superior attention to detail.
- Experience with Quality System Documentation and good documentation practices.
- Knowledge of ISO, and FDA QSR concepts and guidelines.
- Strong prioritization and organizational skills.
- Strong interpersonal skills and ability to work with others in a positive and collaborative manner.
- Ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
- Passion for personal and professional growth and development.
- Ability to work effectively with minimal supervision.
- Demonstrate a bias for action.
- High School Diploma or GED required.
- 3 years of experience in Electronic Document Management Systems or related field preferred.
- Certification in document control or quality management (e.g., ASQ, ISO) a plus.
Language Skills:
Excellent written and verbal communication skills.
Computer Skills:
- Ability to utilize word-processing and database applications including MS Office applications Word, Excel, Access, as well as Adobe Acrobat, etc.
- Experience with manufacturing ERP systems a plus
- Sitting, 6 hours per workday
- Standing, up to 2 hours per workday
Office environment
Travel Requirements:
Minimal
Dedication to the Quality System (Required)
Our objective is to provide a system that promptly detects non-conformances and provides timely and effective control and corrective actions. This Quality System establishes an effective means of assuring product quality. Our policy is to provide full compliance with the Quality System throughout all facets of contract performance and the order fulfillment process. This ensures that all of our products and services meet or exceed the expected company standards as well as those of our customers and the ISO 13485 International Standard, CMDCAS, FDA, and MDD regulations. We operate the Quality System as an overall management system for all products. Our approach to quality is based on the premise that we can achieve product quality and effective cost control by concentrating on the integrity of processes and preventative measures rather than after the fact detection.
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Source : Drucker Diagnostics
