Cirtec Medical · 2 hours ago
Quality Document Control Specialist
Lowell, MA
Full-time
Onsite
Entry Level
$22/hr - $28/hr
2+ years expCirtec Medical is a leading outsourcing partner for complex medical devices, specializing in comprehensive solutions for Class II and III devices. The Quality Document Control Specialist will implement and maintain the Engineering Change Notice System, ensuring proper documentation and coordination between various teams for product improvements and new product development.
Medical Device
Responsibilities
Responsible for issuing part numbers, ECN's, processing documents into QMS and ERP software (Oracle, MasterControl, M2M)
Communicate with customer(s) to obtain ECN approval
Compile and maintain control records (release drawings, project documents, quality system documents, and manufacturing documents)
Manage electronic changes to documents, release documents, and notify affected departments accordingly
Maintain related Document Control files
Ensure documents are filed correctly and maintained per established procedures
Perform database searches, minor data analysis, and report to assist QA Teams
Maintain logs and update CAPA, NCMR, Complaint, and other Quality System files
Prepare reports and memorandums, as needed
Ensure proper upkeep and archival of quality records and documents
Coordinate training program, including facilitating the training and input results into the training QMS systems
Provide support to audits
Complies with company, quality, and safety standards, policies, and procedures
Qualification
Required
Minimum of High School Diploma or GED required
2+ years of Document Control experience in Medical Device industry
Strong knowledge in implementing, processing, and maintaining company and customer documentation in ERP and PLM systems
High attention to detail and critical thinking aptitude
Flexible and self-driven/motivated
Fluency in English (reading, written, verbal)
Proficient with Microsoft Office (specifically Word/Excel)
Knowledge of document control procedures with data storage, maintenance, revision, and archival background
Familiarity with FDA Quality System Regulation (QSR) and ISO 13485
Ability to work on site (commute) daily to the Lowell facility (this is not a remote position and will not consider relocation)
Preferred
some college preferred
Benefits
Training and career development
Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid Time Off
401(k) retirement savings with a company match
Company
Cirtec Medical
Whether you’re a cutting-edge startup or a leading Class II or III medical device manufacturer, Cirtec is here to help bring life-enhancing therapies to market – quickly and cost-effectively.
1001-5000 employees
H1B Sponsorship
Cirtec Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (4)
2022 (2)
2021 (3)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Brian Highley
CEO
John Kraus
Chief Operations Officer
Recent News
2025-10-02
2025-09-17
2025-08-29
Company data provided by crunchbase