Quality Inspector

7 maanden geleden

Haarlem, Nederland Panda Voltijd

**Job Vacancy**

**Your New Company**

Our company has been a pioneer in genetic analysis solutions for over a decade. As the inventors and manufacturers of innovative assays for genetic screening, we provide the world with simple solutions to genetic inquiries.

As a successful, growing biotechnology company located in Amsterdam, the Netherlands, we offer a young, dynamic, and multinational working environment. If you are passionate about providing the world with simple and affordable solutions to detect genetic aberrations and enjoy a vibrant, family-friendly work environment, come join our team

**Where Will You Work?**

You will be part of a team of Production Support Specialists. This work takes place in a controlled environment, including pressure control, temperature control, and microbiological control. You will collaborate with all employees from the factory to deliver a product that meets high-quality standards.

You will report to the Production Support Manager.

**What Will You Do?**

As a QA Inspector, you are responsible for the development, implementation, coordination, monitoring, and management of one or more specific QA processes of the ISO 13485 certified quality management system. You assist in ensuring that the company and its products meet standard and regulatory requirements. This function requires understanding and knowledge of the ISO 13485 and related quality and risk management standards applicable to In Vitro Diagnostics and Research Use Only products. Also, you provide advice and guidance to staff concerning quality. You collaborate with different departments within the company (RA, QC, Product Development, Technical Support, etc.) on projects and ensure processes are aligned. You are part of the QA Team, which currently consists of four colleagues, and you report directly to the QA Manager.

**Key Responsibilities**:

- Process owner of certain QA processes.
- Implementing and updating QA procedures (responsible for Change Control, Discontinued Products).
- Training of functionaries.
- Monitoring and providing trend analysis of QA procedures as input for the Management Review.
- Working and assisting colleagues in other QA processes.
- QA representative in product design reviews as part of a Design Team and responsible for QA-related design project deliverables and documentation.
- Product/Batch Release.
- Internal Auditing.
- Collaboration with interdisciplinary teams to stimulate and support continuous improvement.
- Leading and supporting QA-related projects.

**Qualifications**:

- BSc degree in Biology, Biomedical Sciences, or equivalent.
- 1-3 years of relevant working experience in the medical device, pharmaceutical, and/or biotech industries.

**Required Competencies**:

- Adequate knowledge of relevant industry quality and risk management standards (e.g., ISO 13485, ISO 14971) and basic knowledge of relevant international regulations regarding IVDs (e.g., European IVD Regulation (EU 2017/746)).
- Adequate knowledge of genetics.
- Fluent written and spoken English (Dutch language is not required, but preferred).
- Well-developed analytical skills.
- Affinity with procedures and processes.
- Pragmatic, proactive, and self-motivated.
- Strong organizational skills, flexible, ability to manage multiple tasks, and attention to detail.
- Able to work alone as well as part of a team.

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