We are looking for en experienced Coda Developer (freelance or agency with single point of contact) that can be our “in-house” Doc Maker and expert in our current Coda solutions to transisition our current ISO 13485 Medical Quality Management System to a new CODA+ based environment. We have done most of the preparation on updates yet are targeting a deadline and instead of solving all puzzles we want to work with an expert that not only knows all the tricks in CODA but also integration into GITHUB, GOOGLE, SHOPIFY, EXACT, DOCUSIGN, TRENGO etc, and we meet all the criteria to be fully ISO 13485/ISO 9001 compliant to ensure continuation of certification.
Payment by the hour and potentially a fixed monthly fee for being available for ad hoc support.
Our challenge :
We started using CODA and have some basic documents yet want to intensify this from managing evolving purpose, impact framework based OKR (output, outcome, impact steering) to projects (device and software development) to operational activities from medical device production (EXACT manufacturing) etc.
To create a lean, fully traceable, operationally integrated Quality Management System that:
Complies with ISO 13485, ISO 9001, MDR, FDA 21 CFR 820- Is built on value streams, not bureaucracy
- Embeds quality into execution, not just documentation
- Supports a decentralized, DAO-style organization
- Enables real-time insight, risk management, and decision-making
Deadline : May 2025
Your role
You will be the doc maker for the docs and ensuring we transition rapidly in close working relationship with our company governance team and quality team. You will act in the role for development and implementation of the Quality Management System yet not responsible for the content. You will train the team in how to use and how to manage the system. You transition from doc maker to providing support and review/audit the evolution of the system annually.
- Location: Preferably Europe (we are based in Netherlands)
- Language: English (or Dutch)
- Communication: to be determined
- When? Starting ASAP
- Duration: to be determined,
- Time commitment: dependent on assessment and proposal from your side
- Payment: to be agreed
Interested?
Shoot me a message or reply with your website/details on this post.
Don’t hesitate to reach out with questions
Looking forward to hearing from you!
Thanks
Taco