The Siesta Group Schlafanalyse GmbH is an internationally active company. We are a world leader in the analysis and linking of medical measurement series with a focus on sleep analysis. Our customers from all over the world appreciate our individual solutions, especially in the support of medical studies. Become part of our excellent team where there is something new to learn every day!

QA Specialist

Tasks

A Quality Assurance (QA) Specialist in the clinical trial field is ensuring that clinical trials meet potential regulatory requirements, industry standards, and internal company policies. Their responsibilities include:

• Compliance Monitoring:
• Ensuring that all company procedures comply with Good Clinical Practice (GCP), regulatory requirements (e.g., FDA, EMA), and standard operating procedures (SOPs).
• Keeping up-to-date with changes in regulations and guidelines that affect clinical trials.
• Audit and Inspection:
• Preparing for, facilitating and leading external audits and inspections by regulatory bodies.
• Following up on audit findings and ensuring timely resolution of issues.
• Complete RFP and Vendor Qualification Questionnaires
• Quality Management Systems (QMS):
• Developing, implementing, and maintaining quality management systems to ensure continuous compliance with regulatory requirements.
• Creating and updating SOPs, work instructions, and quality policies.
• Training and Education:
• Providing and supervising training on GCP, SOPs, and regulatory requirements.
• Conducting refresher courses and updating staff on new regulations and best practices.
• Risk Management:
• Identifying and assessing potential risks in clinical trial processes.
• Developing and implementing risk mitigation strategies to minimize the impact of identified risks.
• Continuous Improvement:
• Audit results to identify areas for improvement.
• Implementing corrective and preventive actions (CAPA) to address deficiencies and improve trial processes.

Requirements

• Ideally you have a Master degree in biotechnology field and/or in Medical device field or similar education
• You have already gained some work experience
• You have a strong understanding of Quality regulatory standards/guidance documents.

Offer

If this job description sparked your interest and if you find your profile matching the profile we are looking for, please contact us.

We are very much looking forward meeting you in a virtual meeting and talking to you about our company, our team of developers, and the future perspectives we envision.

Salary

The collective agreement minimum salary is 3,175 EUR gross per month (on a 38.5-hour basis). The actual salary depends on your qualifications and experience and is between 3,175 EUR (Einstiegstufe) and 3,900 EUR (Regelstufe) gross per month (on a 38.5-hour basis). The salary is paid 14 times per year.

• Full remote work possible
• Lots of creative freedom
• Flat hierarchies
• Individual support for your further training
• Partial reimbursement for the Klima Ticket and Jahreskarte

About this job

Employment type

Full Time (Permanent employment)

Salary

44,450 EUR to 54,600 EUR yearly

Seniority level

Professional Experience

Place of work

Wien 21. Bezirk (Floridsdorf)

Field of work

Engineering, Technical Jobs, Science, Research

Unfilled vacancies

1 vacancy unfilled for this position

About the company

Employer

The Siesta Group Schlafanalyse GmbH

Number of employees

11 - 30 employees

Locations

Wien

Details about this job

Full Time (Permanent employment)

• Monday to Friday
• 38,5 hours

Place of work

• Wien 21. Bezirk (Floridsdorf)

Required languages

• English B2
• German B2

Nice-to-have languages

• French A2

Benefits

• Transportation allowance
  - Full remote work possible - Lots of creative freedom - Flat hierarchies - Individual support for your further training - Partial reimbursement for the Klima Ticket and Jahreskarte

All infos regarding your application

Reference number:

QAS2025_07

Required application documents:

• Résumé
• Cover letter