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Senior Quality Engineer
S3 Connected Health
- Świętego Mikołaja 19, Stare Miasto, WrocławWrocław, Lower Silesia
- offer expired 3 months ago
- contract of employment, B2B contract
- full-time
- senior specialist (Senior)
- full office work, hybrid work
- Immediate employment
- remote recruitment
S3 Connected Health
Świętego Mikołaja 19
Stare Miasto
Wrocław
Your responsibilities
Create and maintain quality management system procedures to support regulatory and quality compliance
Monitor, analyze, and improve the effectiveness of the quality management system
Develop corrective actions, solutions, and improvements
Support the D&D processes and ensure the requirements of specifications, standards and regulations are complied
Provide regulatory advice and guidance throughout the complete product lifecycle: Requirements, Design, Verification & Validation, Commercialization and Maintenance
Collaborate with S3 Connected Health teams and customers to develop and implement regulatory strategies and pathways for medical devices
Conduct internal audits and ensure timely follow through on resolution of related audit findings
Support S3 Connected Health certification (e.g., ISO 13485), customer and other regulatory audits
Participate in the evaluation and approval of S3 Connected Health suppliers
Provide quality and regulatory related trainings
Our requirements
Master’s degree in engineering, scientific, or technical discipline
Working knowledge as Quality Engineer having contact with medical device regulatory or other regulated business (e.g. automotive, aerospace, etc.)
Proven practical experience with medical device standards such as ISO 13485, ISO 14971, IEC 62304 & IEC 62366
Considerable knowledge of medical device software and/or hardware development and production
Excellent interpersonal, written, and verbal communication skills (English)
Ability to represent the company during audits (2nd part and 3rd part)
Ability to work independently and effectively without supervision
Shows an organization & business awareness, including customer focus
Capability to solve complex problems
Ability to demonstrate the process behind the thinking
Optional
Structuring and managing medical device technical files
Validation of automated systems used for GxP activities
Medical device risk management in accordance with ISO 14971
Experience working with software systems that support regulatory compliance e.g. eDMS
Medical device post-market surveillance and medical device regulatory reporting
Planning and preparation of regulatory submissions in EMEA, US and other markets for new products, product changes and re-registrations as required e.g. CE Marking, 510(k)
What we offer
Unique opportunity to work in the medical market
Contact with the latest technologies
An excellent learning environment with prospects for career advancement
Opportunity to work with other talented professionals
International projects
Working hybrid or onsite (Wrocław office)
Referral bonus
Private healthcare, life insurance, and Multisport card
Benefits
private medical care
sharing the costs of foreign language classes
sharing the costs of professional training & courses
life insurance
flexible working time
fruits
integration events
corporate library
no dress code
employee referral program
S3 Connected Health
S3 Connected Health is an exciting digital health company headquartered in Dublin, Ireland.
At S3 Connected Health, we are passionate about health and technology and how they can improve the lives of millions of people. We are looking for people who share this passion and who want to turn this passion into practical realities that improve patients’ health and quality of life.
We are a 200-strong team of clinicians, behavioral scientists, system design engineers, UX professionals, data scientists, and strategy analysts who believe in the transformative power digital technologies can have as a vehicle for healthcare delivery and to improve patients' lives.
As Connected Health Senior Quality Engineer you will work with our highly skilled development teams, creating state-of-the-art solutions for remote patient monitoring, medication adherence and monitoring, patient support, and patient engagement.