Quality Assurance R&D Specialist

Quality Assurance R&D Specialist (m/w/d)

Location:

Nieder-Olm, DE

Job Family:
Quality Assurance

Country/Region:
Germany

Quality Assurance Design Development Specialist (m/w/d)

ISO 14971 (Risikomanagement)

________

EN - Job Advertisement

To strengthen our team, we are looking for the next possible date for a

Job scope: fulltime, 40 hrs per week

• Represents Quality Assurance in all development project teams, ensuring the compliance of the product under development to relevant development processes (i.e. design control, risk management, HF engineering) as well as applicable technical standards and regulations
• Reviews and approvals of all the DHF relevant documentation generated all along design and development and lifecycle
• Guides and supports project teams in document management best practices (GDP)
• Provides Quality assurance, oversight and consultancy in all technical, risk management and human factors activities during development projects, i.e. potentially from early scoping/feasibility through development until design transfer and industrialization
• Support in quality (assurance) related aspects with innovation projects internally as well as with external customers and development partners
• Builds up and maintains interfaces with quality management units in production/operation such as production engineering for process validation and quality control for test method validation and execution Supports the implementation of Quality by design concepts relevant for development (control strategy)
• Coordinates and supports the implementation of internal service level agreements if required
• Lead/supervises the change & deviation management during development and beyond
• Chairs and/or participates in Design Reviews related to new product development and sustaining engineering activities.
• Support within Change control Activities for Change plan Approval and Quality support in Change Controls

University degree (Diploma, Master’s, or Bachelor’s) in Engineering, Biomedical Engineering, Mechanical Engineering, Biochemistry, or a comparable technical field

At least 5 years of professional experience in quality management of medical devices or within the pharmaceutical industry

At least 5 years of experience in R&D projects and the design control process

Solid, hands‑on knowledge of relevant standards and regulations, including:

• ISO 13485 (Quality management for medical devices)
• IEC 62366 (Usability engineering – desirable)
• MDR/IVDR and 21 CFR 820.30

Practical experience in product lifecycle management of medical devices

Strong communication and analytical skills with a structured and solution‑oriented working style

Fluency in German and English, both written and spoken

Proficiency in MS Office applications

Strong collaboration skills with international partners and teams; fluent communication in English and German

Proactive, self‑driven, and results‑oriented with excellent communication and self‑management skills

Confident and assertive personality with the ability to influence and motivate others

Independent, efficient, and detail‑oriented work approach; flexibility to act as a team player and facilitator as needed

Strong commitment, initiative, and sense of responsibility

Experience working in an international environment

Willingness to travel within the EU (10–20%)

• A secure and responsible job in a successful team
• A welcoming culture and structured induction programme
• A friendly working atmosphere and colleagues who treat you as equals
• Idea management, freedom to help shape processes and work independently
• Active promotion of your professional and personal development through internal and external training programmes
• Flexible working time models and the option of mobile working (up to 2 days per week)
• Company events, free parking and much more...

Take the first step and apply on the careers page of our homepage by clicking on ‘Apply now’.

Founded in 1986, Atos Medical is the global leader in laryngectomy care as well as a leading developer and manufacturer of tracheostomy products. We are passionate about making life easier for people living with a neck stoma, and we achieve this by providing personalized care and innovative solutions through our brands Provox®, Provox Life™ and Tracoe.

We know that great customer experience involves more than first-rate product development, which is why clinical research and education of both professionals and patients are integral parts of our business.

Our roots are Swedish but today we are a global organization made up of about 1400 dedicated employees and our products are distributed to more than 90 countries. As we continue to grow, we remain committed to our purpose of improving the lives of people living with a neck stoma.

Since 2021, Atos Medical is the Voice and Respiratory Care division of Coloplast A/S