QA/RA Officer

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QA/RA Officer

Terumo Europe

Netherlands

Job Summary

Support QA&RA manager in driving Quality & Regulatory compliance while aligning with the overall organization to meet business needs & objectives;
Support maintenance of Technical dossiers – including preparing necessary documentation - for all Quirem Medical’s products. Technical dossiers support global regulatory requirements for MD;
Monitor regulatory developments and assessing business impact, preparing related GAP-assessments and GAP-closure programs;
Assure Quality & Regulatory compliance in product and process development and change projects;
Support initiatives to improve the quality and manufacturing efficiency of Quirem products;
Be or become (lead) auditor for Quirem Medical’s QMS;
Manage multi-disciplinary teams, supporting completion registrations, QMS and Technical Dossiers.

Job Responsibilities

Support the preparation of an up-to-date Technical Dossier, Design History File, in accordance with the relevant regulatory requirements and standards for relevant jurisdictions (e.g. EU, USA, Canada) for all TIO’s products;
Contribute to the QA&RA strategy related with a global marketing strategy of the TIO/Quirem Medical products, including defining the relevant regulatory frameworks and the product registration and technical documentation requirements;
Maintain up-to-date QMS-documentation under responsibility of the QA/RA department. Proposes and implements optimizations where possible. Makes sure, procedural interactions within the QMS are identified and maintained in accordance;
Coordinate – multidisciplinary and regional or global – projects to maintain or obtain regulatory approval or compliancy, in accordance with the business needs in countries or regions where TIO/Quirem Medical’s products are or will be marketed;
Actively support the QA&RA manager in:
- Ensuring that the business remains compliant with local, federal and global quality system regulations applicable to the products manufactured, sourced by, distributed and installed or serviced by Quirem;
- Advising on Quality & Regulatory standards applicable to the business being served;
- Preparing GAP-assessments relevant for Quirem Medical’s business, resulting from new or changed Rules & Regulations or Standards;
- Coordinating, and executing GAP-closure projects/activities and changing existing or implement new procedures where required, consecutively;
- Resolving customer or supplier inquiries related with product quality- or regulatory affairs related matters.
Act as an expert in the Quality & Regulatory function by actively supporting the development of Quality systems. Be able to implement and maintain a (new/revised) QS-platform;
Ensure the proper implementation of and oversee CAPA (Corrective and Preventative Actions), validations, inspections, document control, regulatory affairs, and problem resolution, acting as an advisor. Maintains an effective CAPA process and CAPA e-platform.

Profile Description

Expertise demonstrated by either of the following qualifications (A or B):
- A) BSc/MSc degree or higher in science, engineering, medicine with 3+ years of relevant experience in medical device and 2+ years in regulatory affairs or QA&RA, including QMS;
- B) 3+ years in pharma/biotechnology in a QA&RA function and 2+ years of relevant experience in medical device regulatory affairs, including QMS.
The following expertise or experience is a must:
- In-depth knowledge of medical devices regulatory frameworks, considering:
  - applicable standards such as ISO 13485:2016, ISO 14971:2019 or other applicable global quality and regulatory frameworks and standards;
  - Medical Devices Software product development and technical dossiers. Knowledge of relevant medical device software standards including IEC62304;
  - Medical Devices (class III, active implantable) in the EEA (incl. MDR, AIMDD, MDD);
  - Knowledge regarding US FDA CFR and Health Canada regulations would be a plus.
- Extent project management experience. Working in multidisciplinary and international teams.
The following expertise or experience is a plus:
- Experience in and preferably certified as (lead) auditor for EN ISO 13485:2016 and MDSAP (ISO 13485:2016);
- Ability to work with different software packages and a document management system.
The following skills will be important for success:
- Excellent interpersonal skills and communication skills, written and oral, in English plus another European language;
- Motivated and accurate. Striving for optimal quality in own work and that of others. Demonstrates ownership and curiosity and continuously looking for improvement without losing practicality out of sight. Likes organizing and providing structure. Hands-on. Flexible whenever the ‘dynamics’ of the job ask for it.