Oferta pracy

Senior Quality Engineer

S3 Connected HealthAbout the company

S3 Connected Health

Świętego Mikołaja 19

Wrocław

Your responsibilities

  • Collaborate with S3 Connected Health teams and customers to develop and implement regulatory strategies and pathways for medical devices

  • Provide regulatory advice and guidance throughout the complete product lifecycle: Requirements, Design, Verification & Validation, Commercialization and Maintenance

  • Maintain excellent knowledge of current and emerging global regulatory requirements for the design and marketing of medical devices, medical device software (SAMD), and connected health systems

  • Create and maintain quality management system procedures to support regulatory and quality compliance

  • Conduct internal audits and ensure timely follow through on resolution of related audit findings

  • Provide quality and regulatory related training to new and existing employees

  • Support S3 Connected Health certification (e.g. ISO 13485), customer and other regulatory audits

  • Participate in the evaluation and approval of S3 Connected Health supplier

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 in 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 with minimal supervision

  • Shows an organization & business awareness, including customer focus

  • Capability to solve minor and 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

  • Working with the latest technologies

  • Great learning environment with prospects for career advancement

  • Opportunity to work with other talented professionals

  • Competitive salary with private health insurance, life insurance & other social benefits

  • Many sports activities & sport cards

  • Daily fruits and sweet Mondays

  • Benefits

  • sharing the costs of sports activities

  • private medical care

  • sharing the costs of foreign language classes

  • life insurance

  • remote work opportunities

  • flexible working time

  • fruits

  • integration events

  • corporate library

  • no dress code

  • charity initiatives