Quality/ Regulatory Consultant

SIRE Life Sciences
Geplaatst op
Binnen een jaar
Meer dan 15.000 euro
Op locatie


Looking for Q&R person with medical device experience, knowledge of CFR 820 & ISO 13485.

Area of focus will be processes associated with manufacturing in the End2End program Plan2Finished goods. The project is to embed Q&R requirements into new process designs, confirm Q&R controls are tested in the software validation of the project or included in the instructions of the new processes. Once software is validated, processes are designed, documents are released, the candidate will create quality transition plans for the deployment to markets and BG’s. These plans will be communicated to the local Q&R leaders for them to take action.

The company is looking to hire consultant(s) with Quality Medical Device experience for at least six months. Contract may be extended depending on the project needs.

Location: Based out of Eindhoven Netherlands with possible travel once every other month.

Main Obligations

With direction from identified Quality & Regulatory Program or Project leads

  • Manage the program and/or project as it applies to effect on Quality Management System through use of Quality Plan(s).

  • Work with program and project teams, including Subject Matter Experts (SME), from the business and Q&R to perform the review and incorporation of Quality System Regulations into the processes down to the level of work instructions. (Iterative approach, ie. merge new with legacy based upon SME Team input, send out for review, update per feedback, iterate until final solution for release.)

  • Work with same program and/or project teams on supporting User Requirement definitions, etc. in support of the Software Tool(s) that support of the procedures from previous bullet.

Note: Project Teams include cross functional Local Business (including Q&R) and End to End (E2E) representatives (including E2E Q&R), covering moving from Legacy to Future E2E state for Processes and SW Tools.

Consultant Coverage for each assigned Program/Project as listed

(All include oversight direction from our Q&R team)

  1. Overall Program/Project Support

  1. Support the overall program all sub-projects identified in the program

  2. Hands on work in Business Process Framework (PBPF)

  • Using new high level processes that define “What” we do and a set of User Stories polled from the businesses and gathered by the program and/or project teams, support the teams to ensure the “How” aspects to be built into the procedures, instructions, templates, etc. include applicable Quality System Regulations activities that apply to Quality Management System (QMS)

  1. Business Process Framework (BPF) E2E Deployment

  1. Create write, update & maintain Quality Plan(s) in conjunction with the teams and Q&R, to meet Program/Project planning

  2. For Project teams, support GAP analysis of Legacy vs. E2E processes and procedures

  3. Merge, write, create, thru release the bullet 1c procedures, instructions, forms and templates for Project Teams as directed

  1. Integrated Landscape (IL) SW Application Platform(s)

  1. Support the Project teams by communicating visibility as regard to

  2. The process gaps between configured enterprise applications and compliance requirements.

ii. Alignment between the Quality Plan(s), V&V Plan(s) and Deployment Plans in respect of legacy / transition / future (PIL) application landscapes … i.e., a moving target

This project may take up to 1,5 year.

Please contact me if interested.

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