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Quality Engineer

S3 Connected Health

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 effectiveness of 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

  • Ability to demonstrate the process behind the thinking

Our requirements

  • Master’s degree in engineering, scientific, or technical discipline

  • Working knowledge as Quality Engineer

  • Proven practical experience with standards

  • Excellent interpersonal, written, and verbal communication skills (English)

  • Ability to work independently and effectively with minimal supervision

  • Shows an organization & business awareness, including customer focus

  • Capability to solve complex problems

Optional

  • Experience in medical device standards such as ISO 13485, ISO 14971

  • Experience working with software systems that support regulatory compliance e.g. eDMS

What we offer

  • Fixed-term employment contract for 2 years

  • 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

  • Flexible working hours

  • Working hybrid or onsite (Wrocław)

  • Referral bonuses

  • Private healthcare, life insurance, and Multisport card

Benefits

  • sharing the costs of sports activities

  • 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 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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