Quality Management System Specialist

BHS Technologies GmbH; Osterreich; Hybrid; PEN 271,000 - 426,000; Full time

Job summary

BHS Technologies GmbH is seeking a Quality Management System Specialist (QMR) to manage the ISO 13485 and MDR-compliant quality system and drive its ongoing improvement. You will be the main contact for Notified Bodies, authorities and auditors, and you will shape digitalised processes across the organisation.

You report to Management and collaborate with Regulatory Affairs, R&D and all departments to ensure robust quality practices and effective compliance across the business.

Qualifications

• 5+ years of experience in quality management, ideally at a medical device manufacturer.
• Experience with ISO 13485, MDR and related standards.
• Auditing experience with QM training (e.g. QM training certificates).
• Fluent in German and English.
• Process thinking and pragmatic implementation across processes.

Responsibilities

• Operate quality management system in line with ISO 13485 and MDR.
• Be the first contact for Notified Bodies, authorities and auditors.
• Shape digitalisation of processes and prepare input for strategy processes.
• Collaborate with Regulatory Affairs, R&D and all departments.

Skills

Project Management

Quality management

Communication skills

German and English

Education

Engineering degree

Tools

Jira

Confluence

Jama Connect

Job description

Quality Management System Specialist / QMR

(f/m/d)

As Quality Management System Specialist, you run our management system in line with ISO 13485 and the MDR, and develop it further towards business excellence. You are the first point of contact for our Notified Body, authorities and auditors, help shape the digitalisation of our processes and prepare input for our strategy process. You report directly to the Management and work closely with Regulatory Affairs, R&D and all departments.

Areas of Responsibility

• Degree (university or university of applied sciences) in engineering, natural sciences, medical technology or industrial engineering – or an equivalent qualification with relevant experience
• At least 5 years of experience in quality management, ideally at a medical device manufacturer
• In-depth knowledge and experience in dealing with and implementing standards and regulations
• Experience in the further development of integrated management systems within a complex and wide landscapeof international standards and regulations
• Certified QM training (e.g. Quality Austria, TÜV) and experience in conducting audits
• Fluent in Project Management
• Confident with common Office Software and ticket systems (e.g. Jira)
• Process thinking, structure and a high degree of flexibility on technical questions – you implement requirements pragmatically: as much as necessary, as lean as possible
• Strong communication skills, assertiveness and enthusiasm for getting people excited about importance and meaning of quality
• Very good German and English (main languages spoken in the company)

Nice to Have

• Solid knowledge of ISO 13485 and the MDR, as well asISO/IEC 27001, ISO 37301, EFQM or MDSAP
• Auditor qualification according to ISO 19011
• Experience with Confluence, ALM tools (e.g. Jama Connect) and computer system validation
• Experience with Notified Body audits
• Experience in start-ups or fast-growing organisations

Your future working environment

At BHS Technologies, we highly value teamwork and appreciate every opinion. Therefore, decisions are made together and your opinion counts from day one!

Our communication is open, questioning the status quo is our daily business. The characters and interests in our team are diverse and colorful, and we all work together to ensure that there is enough freedom for each character. What we do together is varied, very challenging and above all: very interesting!

Beyond daily work, team members regularly connect outside the office, whether through shared activities, informal gatherings or time spent together after work.

The BHS Leadership Team

BHS Technologies is led by Michael Schmid-Santek, CEO, Gregor Burger, CTO Software and Mark Capelli, CTO Hardware. The leadership team works closely with employees across teams, values direct communication and supports collaboration between development, service and commercial functions.