Quality Document Control Specialist

Description

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

The Quality Document Control Specialist implements and maintains the Engineering Change Notice (ECN) System. The role will be responsible for product improvements, repairs, and new product development. They will coordinate the interaction between engineering, manufacturing, field operations, and marketing teams in order to ensure appropriate changes are properly and efficiently documented. The Specialist will provide documentation such as Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) procedure manuals and change authorization in accordance with company policies and government relations. The ideal candidate for this role will be a collaborative representative on the quality team with an internal-customer focus and hold high attention to accuracy and efficiency of processes.

Key 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.

This is not a remote position.

Must Have:

• Minimum of High School Diploma or GED required; some college preferred.
• 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).

Anticipated Pay Range: $22 - $28/hour based on skills and qualifications.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.