Sr. QA Specialist

Ready to make a real impact on quality in the world of molecular diagnostics?

PathoFinder is looking for a hands-on Senior Quality Assurance Specialist to strengthen our Quality team and help ensure the highest standards across our Quality Management System.

In this role, you will combine hands-on quality assurance with technical leadership. You will coordinate priorities, support audits, guide colleagues and play a key role in continuously improving our ISO 13485 and IVDR compliant Quality Management System.

Working closely with cross-functional teams, you will help ensure that innovative molecular diagnostic products reach customers with the highest level of quality and compliance.

Company profile

PathoFinder, founded in 2004, is a molecular diagnostics scale-up company based in Maastricht. The company develops and commercializes innovative molecular diagnostic tests for comprehensive detection of a wide variety of infectious disease pathogens, including SARS-CoV-2. PathoFinder's proprietary 2SmartFinder® technology enables the detection and differentiation of up to 24 viral, bacterial, fungal and parasitic pathogens in a single assay.

PathoNostics, founded in 2011, is PathoFinder’s sister company and is focusing on the development and manufacturing of real-time PCR assays for fungal diagnostics. Our mission is to rapidly detect the disease-causing fungus and simultaneously identify antifungal resistance, allowing clinicians to initiate a dedicated and timely therapy and save on costs and lives.

Both PathoFinder and PathoNostics are ISO13485 certified, and all products comply with CE-IVD guidelines.

Why join us?

· Innovative Environment: Be part of a team that is at the forefront of molecular diagnostics.

· Supportive Culture: We believe in teamwork, open communication, and celebrating successtogether.

· Impactful Work: Make a difference in the molecular diagnostics industry and contribute to our mission.

Key Responsibilities:

· Maintain and improve the QMS (ISO 13485 & IVDR).

· Manage core QA processes.

· Lead investigations, CAPAs and root cause analyses.

· Support product quality, validation and risk management.

· Conduct internal and external audits.

· Improve the eQMS and quality processes.

· Coordinate daily QA activities and provide technical guidance.

· Deputize for the QA Manager when required.

Skills and Requirements:

· BSc or MSc in Molecular Biology, Applied Science, Life Sciences, or a related field.

· 3-5 years’ experience in Quality Assurance within the medical Device or IVD industry.

· Proven experience maintaining and improving Quality Management Systems compliant with ISO 13485 and IVDR.

· Solid experience with CAPA, Change Control, Risk Management, Internal Audits and Regulatory Compliance.

· Experience with eQMS platforms (e.g. Greenlight Guru or similar) is highly desirable.

· Strong analytical, problem-solving, and attention-to-detail skills.

· Excellent communication and cross-functional collaboration skills.

· Demonstrated ability to provide technical leadership and coordinate QA activities.

· Ability to lead by example while remaining hands-on in daily QA activities.

· Fluent in English, both written and spoken.

What we offer:

· An exciting role in an innovative and growing molecular diagnostics company.

· Competitive salary and excellent employment conditions.

· 25 vacation days and a company-funded pension plan.

· A collaborative team with opportunities for professional growth.

Interested? We would love to hear from you!

Please send your CV and motivation letter to: HR@pathofinder.com.

Arbeidsvoorwaarden:

• Bedrijfsfitness
• Flexibele werkuren
• Kerstpakket
• Kosteloos parkeren
• Pensioen

Taal:

• engels (Vereist)

Werklocatie: Fysiek