QA Engineer (R&D, Design Control) – Praca Poznań Sady, Tarnowo Podgórne

Lina Medical; Poznań; Hybrid; PLN 90,000 - 130,000; Full time

Benefits offered by this job

Private medical care

Sports card

Flexible working time

English lessons

Job summary

Lina Medical in Poland is seeking a quality/engineering professional to join its R&D team focusing on new medical devices and sustaining existing products.

The role emphasizes leading risk management, usability, and design verification & validation, with hands-on work in metrology and lab environments, collaborating with regulatory officers and suppliers to ensure compliance with ISO 13485, ISO 14971, and MDR requirements.

Qualifications

• Minimum 2 years in Quality or Engineering, ideally in Medical Device Industry.
• Master’s degree in engineering (prefer Engineering Management, Quality Management, Biomedical Engineering).
• Knowledge of ISO 13485, ISO 14971, IEC 60601-1, IEC 62366, ISO 11607, ISO 10993.

Responsibilities

• Participate in R&D projects for new medical devices and maintain existing products.
• Lead risk management, usability, design verification and validation.
• Perform root cause analysis, NC & CAPA processes.
• Prepare quality and technical documentation for design, testing, and regulatory purposes.
• Collaborate with project teams, clinical experts, regulatory officers and suppliers.
• Report to line manager and project manager.

Skills

QA in medical devices

Risk management

Usability engineering

Design verification & validation

Root cause analysis

CAPA processes

Team collaboration

Prioritization

Education

Master's degree in engineering

Tools

Quality tools

Job description

Responsibilities :

Participation in R&D projects for new medical devices development and maintenance of released products with following duties:

• Responsibility of QA aspects in development phase of new projects and sustaining already manufactured products from quality perspective
• Leading role in activities like risk management, usability, design verification & validation
• Involved in problem solving activities, root cause analysis, NC & CAPA processes
• Work in line with Quality Management System procedures and international standards and regulations, relevant for Medical Devices (like ISO 13485, FDA 21 CFR 820.30, MDD 93/42/EEC, MDR 2017/745, ISO 14971)
• Analyzing state of the art for similar products and defining input requirements for projects, in line with relevant safety product standards (like IEC 60601-1, ISO 10993)
• Participation in designing and executing pre-clinical tests
• Preparation of quality and technical documentation related to design development, testing, and regulatory purposes
• Cooperation with project teams, clinical experts, regulatory officers, technical consultants and suppliers
• Reporting to line manager and project manager

Requirements :

• Minimum 2-years (>5-years is preferred) of experience in Quality or Engineering, ideally in Medical Device Industry
• Master?s degree in engineering (preferable: Engineering Management, Quality Management, Biomedical Engineering)
• Knowledge of relevant industry standards (like ISO 13485, ISO 14971, IEC 60601-1, IEC 62366, ISO 11607, ISO 10993) will be advantage
• Knowledge and ability to apply quality tools and methods
• Experience with metrological and laboratory equipment. Willingness to work ?hands on? with device
• Ability to work in a Team and prioritize own workload

We offer:

• Working in the R&D department in an international, interdisciplinary team
• Great atmosphere in the office and interesting challenges
• Opportunity to grow with the organization and build a successful career path
• A number of benefits (private medical care, sports card, flexible working time, English lessons)

Please add the following clause: I consent to the processing of my personal data for the purposes of the recruitment process (in accordance with the Act of May 10, 2018 on the protection of personal data (Journal of Laws of 2018, item 1000) and in accordance with the Regulation of the European Parliament and Council (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46 / EC (GDPR)).