Role QA-RA Specialist
Location Salzburg
Responsibilities
Plan and deliver post‑market surveillance activities (PMS, PMCF, PSUR, SSCP), ensuring compliance and continuous improvement
Coordinate documentation to support international market approvals (e.g., CFS, regulatory statements)
Execute and document method validations to meet quality and regulatory standards
Analyse quality and environmental trends, driving corrective and preventive actions
Coordinate biocompatibility studies in line with ISO 10993 and maintain up‑to‑date documentation
Maintain risk management activities in accordance with ISO 14971 across the product lifecycle
Develop and maintain quality documentation, and support training across processes and procedures
What You’ll Get
Fixed term – 14 months
May be eligible for annual bonus up to 5%
25 vacation days per year plus public holidays
Wellbeing initiatives
What You Bring
Fluent in German (written & spoken)
Degree in a relevant field (e.g., science or engineering)
3+ years’ experience in QA, RA, or R&D within a regulated environment
Hands‑on experience with quality management systems and controlled documentation
Experience with method validation (and/or qualification activities)
Strong analytical skills with a structured, detail‑oriented approach and ability to meet deadlines
Experience in the medical device sector, including post‑market requirements or regulatory processes is desirable
Knowledge of biocompatibility or risk management standards (e.g., ISO 10993, ISO 14971) would be advantageous
Our approach to Diversity & Inclusion We’re building a workplace where everyone feels seen, heard, and valued. We believe that a diverse mix of people (from different cultures, ages, geographies, and genders) makes us stronger. It brings fresh perspectives, drives better decisions, and helps us deliver solutions that reflect the world we serve. Inclusion isn’t just a value, it’s how we work, grow, and lead together.
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Location Salzburg
Responsibilities
Plan and deliver post‑market surveillance activities (PMS, PMCF, PSUR, SSCP), ensuring compliance and continuous improvement
Coordinate documentation to support international market approvals (e.g., CFS, regulatory statements)
Execute and document method validations to meet quality and regulatory standards
Analyse quality and environmental trends, driving corrective and preventive actions
Coordinate biocompatibility studies in line with ISO 10993 and maintain up‑to‑date documentation
Maintain risk management activities in accordance with ISO 14971 across the product lifecycle
Develop and maintain quality documentation, and support training across processes and procedures
What You’ll Get
Fixed term – 14 months
May be eligible for annual bonus up to 5%
25 vacation days per year plus public holidays
Wellbeing initiatives
What You Bring
Fluent in German (written & spoken)
Degree in a relevant field (e.g., science or engineering)
3+ years’ experience in QA, RA, or R&D within a regulated environment
Hands‑on experience with quality management systems and controlled documentation
Experience with method validation (and/or qualification activities)
Strong analytical skills with a structured, detail‑oriented approach and ability to meet deadlines
Experience in the medical device sector, including post‑market requirements or regulatory processes is desirable
Knowledge of biocompatibility or risk management standards (e.g., ISO 10993, ISO 14971) would be advantageous
Our approach to Diversity & Inclusion We’re building a workplace where everyone feels seen, heard, and valued. We believe that a diverse mix of people (from different cultures, ages, geographies, and genders) makes us stronger. It brings fresh perspectives, drives better decisions, and helps us deliver solutions that reflect the world we serve. Inclusion isn’t just a value, it’s how we work, grow, and lead together.
#J-18808-Ljbffr
