Document Control and Operations Specialist (or Manager)

Boston, MA /
Regulatory Affairs & Quality Assurance /
Full-time
At Cardiologs, our mission is to make tomorrow’s medical diagnosis efficient and accessible to everyone, anywhere, anytime. We leverage machine learning (AI) and cloud computing technologies to fulfill this vision. Our Cardiologs platform is leading software for the analysis of ambulatory ECG used to help diagnose +500,000 patients every year. More recently, we launched a Remote Patient Monitoring solution in the US to help physicians streamline ECG reviews.   

We have an innovative, result-orientated work environment where we foster ambition and dedication while being mindful of our teammates’ work and achievements. We also nurture our company culture with monthly all-hands meetings and apéros, weekly yoga classes, and other fun activities. 

As we continue to grow, we are looking for a Document Control Specialist & Operations to join the team in Boston.

What you will do

We are looking for a Document Control Specialist & Operations to maintain our QMS at Cardiologs. Lead change management in our medical devices and lead in our eQMS activities.

You will:

- Manage activities in areas of responsibility in accordance with quality system procedures.
- Maintain master document control system via the Document Change Order (DCO) process.
- Ensures timely DCO review, approval, incorporation, checking, and release.
- Administer the project document control system to support new product development activities.
- Maintain the external document control system to ensure that all external documents referenced in controlled documents are available.
- Prepare and revises controlled documents in accordance with standard formats. Document types include specifications, procedures, forms, plans, protocols, and reports.
- Coordinate product information language translations with outside services.
- Maintain various lists, logs, and tracking systems related to documents and records.
- Release approved documents including copying, stamping, and distribution.
- Retrieves superseded and obsolete document revisions to prevent inadvertent use.
- Archive, organize and secure various quality records including Design History Files, Device History Records, and Quality System Records to provide for reliable and efficient retrieval.
- Identify training requirements related to new/revised procedures and coordinates training completion.
- Maintains procedure training matrices to ensure that personnel training requirements are defined, training accomplishments are documented, and appropriate corrective actions are taken.
- Manage electronic files in a secure manner to prevent unauthorized changes.
- Coordinates backups of electronic files to ensure recovery of lost data.
- Perform comprehensive document reviews to verify completeness of Device Master Records and generates status reports.
- Works with contract manufacturers to ensure the proper transfer of company requirements into the contractor’s Device Master Records.

General Duties and Responsibilities:
- Establish and maintain quality system procedures related to areas of responsibility.
- Advise and train other Company personnel concerning areas of responsibility.
- Ensure appropriate communication processes are established within and across functional groups.
- Communicate information related to quality management system effectiveness. 
- Represent areas of responsibility in internal and external quality audits.
- Assist with corrective and preventive action planning and implementation.
- Work in accordance with quality system procedures.
- Help with establishing policies, goals, budgets, plans, and procedures related to areas of responsibility.

Who you are

- You have at least 5 years of experience in document control and eQMS activities
- You excel in time management and paying attention to details
- You have excellent organization skills
- You write and speak English - you'll work in an international distributed team

What we value

We value a positive mindset, collaboration, sense of ownership, transparency, the ability to embrace ambiguity, a talk-less-do-more attitude, and a sense of humor to enjoy ourselves along the way. If you identify with our values and want to contribute to our company, we’d love to have you in!

What we offer

- Beautifully by-the-book startup offices in Boston
- A respectful, fun, collaborative work environment
- Flexible WFO/WFH policy
- Yearly team off-sites
Our recruiting process
Being authorized to work in the US is a precondition of employment.

- Quick call with a RAQA team member and a quick introductory HR phone call
- Technical interview in our office or by Zoom
- Performance interview  in our office or by Zoom
- Culture interview (with lunch or drinks with the team if possible!)
- Quick call with our CEO, Yann (only if you did not have the opportunity to meet him in one of the previous interviews)
- Reference calls