Software quality engineer Jobs in Waldbüttelbrunn

We are looking for you as Product Quality Engineer (f / m / d) to manage technical files and provide quality management support for design controls and regulatory requirements for our Respiratory medical device offerings.

This position would ideally be located either in Estenfeld, Germany or in Ankara, Türkiye and can be done partly from home (with being onsite for Audits).

What we offer :

Flexible working hours and working time accounts to support the work-life balance

Support your professional development through internal and external training and certification programs

Competitive Salary plus Annual bonus target (based on EBITDA and personal performance)

Company pension scheme

We have both social and wellness committees that organize parties, events and activities

What you'll be doing :

Ensure Product and Process compliance according to Medical Device and ICH guideline regards to Technical File creation and management, product quality management support, Complaint Handling, CAPA Management, Production & Supply Chain and Clinical Trial Services.

Participate in design control or study teams to provide input on necessary regulatory and quality requirements for design and study projects or changes.

Creation and maintenance of technical files for responsible products.

Supervision and direction of quality assurance activities of all test departments in receiving inspection, production, and process control and final inspection.

Decision upon quality related measures before shipment of products and control execution of corrective measures.

Participate in Internal and external Quality Projects in R&D and Production to assure fulfilment of Quality and Regulatory requirements and Clario Operating Procedures and processes.

Organization and definition of all necessary inspections and testing techniques for the products in relationship with change management, complaint issues, final inspection and production engineering.

Define and Implement Quality Procedures for Complaint Management, CAPA Management, Final Inspection and Change Management in agreement with supervisor.

Perform quality checks on design control, production and study related documentation.

Maintain and execute the change management process in accordance with standard corporate procedures.

Compile change management, CAPA and complaint related KPIs including statistical analysis and periodic reports.

Provide Training to departments on quality regulations and quality processes.

Maintain customer complaint file and support other departments in processing change requests, CAPA and complaints.

Maintain the status of documents in design projects.

Support article introduction during development projects.

Communicate status of Changes, CAPAs and Complaints to other departments.

Adapt Quality Processes to changes in R&D and Production Processes if necessary.

What we look for :

Technical education (Master / Bachelor degree or equivalent) with preferred approximately 2 years’ working experience.

Working experience in quality assurance department or design control projects preferred.

Basic knowledge of 21CFR Part 11, 21 CFR 820, ISO 9001 / 13485, ICH E6 and / or other applicable regulatory standards.

Experience managing CAPAs and complaints.

Excellent skills in analysing issues and processes.

Team oriented with excellent communication and organizational skills.

MS Office applications.

German and English fluent.

At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials.

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