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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.
Qualifications
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.
Responsibilities
- 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.
Application
To apply, please send your resume and a cover letter detailing your motivation to:
