Overview:
The Document Control Lead is responsible for supporting the Quality System that drives the Company’s commercial success. Reporting to the VP QA/RA, the Document Control Lead will aid in ensuring that compliance is maintained, proper documentation is in place and processes are managed in accordance with current policies and practices. The Document Control Lead will have broad interaction with all facets of the organization and will provide support for the overall maintenance and continuous development of OnPoint Surgical’s Quality Management System.
Duties and Responsibilities:
Primary:
- Responsible for daily support of OnPoint Surgical’s Quality Management System (QMS) change control, document and record control processes, ensuring compliance with 21 CFR 820, ISO 13485.
- Support change control and record management at OnPoint Surgical as directed.
- Ensure changes are correctly assessed and controlled within OnPoint Surgical QMS.
- Support the collection, scanning, and filing of records and documents. May includes Batch Records/DHRs, Inspection Records, Calibration Records, NCMRs, audits, and expand into other departments as needed (Customer Service, Field Service, Complaints), etc.
- Responsible for QMS training process, documentation and records.
- Management of the Calibration process including labeling, tracking, scheduling and recall of all instruments and items.
Secondary – Knowledge and Support of:
- May be asked to perform internal audits of the quality system.
- Other duties consistent with support and improvement of the Quality System as needed.
- Act as a backup to the Sr. Quality System Manager as required.
Required Skills and Qualifications:
- Minimum High School education, college degree preferred.
- 4 to 8 years’ experience in managing change control record management and storage processes in a medical device or similarly regulated industry.
- Management of documents and records within a PLM system.
- Ability to prioritize work and manage multiple tasks.
- Self-starter and ability to work both independently and in teams.
- High degree of competency in the use of Microsoft Office products (Word, Excel, PowerPoint, etc.).
- Attention to detail and solid communication skills.
This position will be based in Concord, MA.
Contact: