Key Skills

Job Description

Location: Helmond, the Netherlands Employment type: Interim or employment contract | Part-time or full-time Minimum availability: 2–3 days per week Expected duration: Approximately 3–6 months, with the possibility of a longer collaboration Compensation: Negotiable based on experience and type of engagement About the role Blue Medical Devices is looking for an experienced and hands-on Senior QMS Specialist to support the strengthening and remediation of our established medical-device Quality Management System. This is not an advisory or consultancy-only position. We are specifically looking for someone who is comfortable working directly within the QMS and taking ownership of practical quality-system activities. You will review existing documentation, identify gaps, write and revise procedures and records, investigate legacy issues, prepare supporting evidence and actively drive outstanding quality actions through to closure. The main objective of the role is to further improve the effectiveness and compliance of our QMS while reducing the backlog of legacy quality-system activities. Key responsibilities As Senior QMS Specialist, you will support the organisation with: Reviewing, writing and revising QMS procedures, SOPs, work instructions, forms and templates; Reviewing existing processes against ISO 13485 and EU MDR 2017/745 requirements and implementing practical improvements; Investigating and supporting the closure of legacy CAPAs, NCRs/nonconformities and audit findings; Preparing quality records, investigation summaries, justification memos and other documented evidence required for compliant closure; Performing root-cause analyses and defining appropriate corrections and corrective actions; Reviewing historical QMS records and resolving documentation and traceability gaps; Supporting change controls and related QMS documentation; Supporting complaint handling, PMS and other quality-system documentation where required; Supporting the preparation and follow-up of internal and external audits; Working directly with process owners to obtain missing information and evidence and bring outstanding actions to closure; Improving existing processes and documentation while maintaining a practical and proportionate QMS. Your profile We are looking for someone with: Strong practical experience within medical-device Quality Management Systems; Good working knowledge of ISO 13485 and EU MDR 2017/745; Demonstrable experience personally writing and revising QMS procedures and records; Hands-on experience with CAPA, NCR/nonconformity management, root-cause investigations, change control and audit findings; Experience with QMS remediation, remediation projects or legacy quality-system clean-up; The ability to assess incomplete or problematic quality records, identify what is missing and personally work towards compliant closure; The ability to work independently with limited supervision; A practical and proportionate approach to quality and compliance; Experience within medical-device manufacturing is strongly preferred. What we are looking for We are specifically looking for a hands-on quality professional rather than an advisor. You should be comfortable receiving an existing procedure, an old CAPA or NCR, an audit finding or an incomplete quality record and personally working through the documentation, investigation, supporting evidence and required actions to improve or close it. Working arrangement We are flexible regarding the type and extent of the engagement. The role is open to both interim professionals and candidates who prefer to join Blue Medical Devices on an employment contract. The minimum availability is 2–3 days per week for approximately 3–6 months. Candidates who are available for more days per week or on a full-time basis are equally welcome and may work more hours depending on their availability and the needs of the project. Depending on the activity, part of the work can be performed remotely. However, given the hands-on nature of the role and the need to work directly with process owners, regular presence at our site in Helmond will be required. There may also be an opportunity to discuss a longer-term collaboration depending on business needs, performance and mutual fit. Compensation or interim rate is negotiable and will be determined based on experience, seniority, availability and the chosen type of engagement. Interested? If you are an experienced QMS professional who enjoys working directly within quality systems and turning open or legacy quality issues into practical, compliant solutions, we would be happy to hear from you.

Core Responsibilities

Review, write, and revise QMS procedures and records, assess processes against ISO 13485 and EU MDR requirements, and investigate legacy CAPAs, nonconformities, and audit findings. Prepare evidence and drive quality actions to compliant closure while supporting change control, complaint handling, post-market surveillance, and audits.

Requirements

Candidates need hands-on medical-device QMS experience, working knowledge of ISO 13485 and EU MDR 2017/745, and demonstrated experience writing and revising procedures and records. They should be able to independently investigate and remediate legacy quality issues, manage CAPAs and nonconformities, and work practically with process owners; medical-device manufacturing experience is strongly preferred.