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Oferta pracy
Senior Quality Engineer
S3 Connected HealthAbout the company
- Wrocław, Lower Silesia
- offer expired 10 months ago
- contract of employment, B2B contract
- full-time
- senior specialist (Senior)
- full office work, hybrid work
- Immediate employment
- remote recruitment
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.
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