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22 Aug 2023


QA Specialist at Smart BioMaterials Consortium (SBMC)

Smart BioMaterials Consortium is seeking a skilled QA Specialist who will take charge of SBMC’s quality management system, foster a culture of quality within the organization, and provide guidance to SBMC’s clients for the establishment of their own quality management systems. If you are a proactive individual enthusiastic about ensuring the quality and safety of medical products and thrive in a rapidly evolving environment, this opportunity is tailor-made for you!

 Job Description

In the initial year, your primary focus will be on developing and implementing SBMC’s quality management system, ensuring compliance with regulatory standards such as ISO-13485, the EU MDR, and GMP. Collaborating closely with our QA/RA partner, you will proactively champion SBMC’s quality policy, inspire employees to align with shared values, and foster enthusiasm for adhering to ISO-13485 standards. Post implementation, you will be accountable for the ongoing regulatory compliance of SBMC.

We are seeking a knowledgeable and experienced colleague who possesses the passion and drive to elevate the Quality Assurance processes within SBMC. This role is ideally suited for an individual who thrives in a fast-paced startup environment and relishes the opportunity to solve novel challenges. Substantial prior experience is essential to make a direct impact within SBMC.


A Master’s degree in a relevant field such as biology, biomedical engineering, chemical engineering, biotechnology, or related disciplines.

Work Experience

A minimum of 2 years’ experience in Quality Assurance, preferably within the medical device sector or pharmaceutical industry.


  • Lead the development and implementation of SBMC’s QMS in accordance with pertinent external regulatory requirements, including ISO 13485, EU-MDR, and preferably GMP.
  • Enhance QMS processes, elevate quality and safety awareness, and foster effective communication on quality initiatives to support established quality objectives.
  • Initiate internal audits to ensure QMS effectiveness.
  • Evaluate, review, and audit external suppliers, including supplier selection processes.
  • Maintain internal audit schedules and records, tracking CAPA activities as needed.
    Address quality issues concerning incoming components and collaborate with product suppliers for resolution.
  • Serve as the Management Representative for the QMS, ensuring comprehensive documentation, understanding, implementation, and maintenance throughout SBMC, including staff training.
  • Report QMS performance, suitability, and effectiveness to the CEO, highlighting areas for improvement.
  • Prepare SBMC for external audits, implementing corrective actions to address non-conformities.
  • Maintain communication with QMS and product certification authorities, including notifications of changes.
  • Contribute to the continuous improvement of the quality system.
  • Provide guidance on QA/RA aspects related to product/process changes or extensions.
  • Support SBMC’s clients in implementing their own quality management systems.

Qualities and Skills

  • Profound understanding of quality systems.
  • Proficiency in technical writing, creating SOPs, and developing verification and validation protocols.
  • Familiarity with regulatory frameworks, including ISO-13485, ISO 9001, EU-MDR, and GMP.
  • Knowledge of ML-I/ML-II guidelines (GMOs) is advantageous.
  • Thorough knowledge of internal and external audits.
  • Strong language skills in both English and Dutch.
  • Proactive approach.
  • Effective communication and collaboration skills in a team-oriented environment.
  • Organized, communicative, and adept at planning.
  • Problem-solving and quality-focused mindset.
  • Ability to handle resistance, give and receive feedback.
  • Adaptability to the dynamic nature of a startup.

What We Offer

At SBMC, we are dedicated to accelerating advancements in biomaterials and regenerative medicine. Our organization fosters a collaborative and passionate team culture in a flat organizational structure. Expect a stimulating work atmosphere and an open communication culture. This role entails diverse and challenging responsibilities within an innovative environment with real-world impact.

  • Possibility of permanent employment.
  • Part-time (0.8 FTE) or full-time (1.0 FTE) position.
  • Competitive salary commensurate with qualifications and experience.
  • Inclusive, motivating, and pleasant work environment.
  • Join a rapidly growing and dynamic team.


To apply, please send your resume and a cover letter detailing your motivation to: This email address is being protected from spambots. You need JavaScript enabled to view it.. For additional information, you can contact Jan Rietsema at This email address is being protected from spambots. You need JavaScript enabled to view it.

QA Specialist at Smart BioMaterials Consortium (SBMC)