Senior Quality Assurance Specialist
2 tygodni temu
As a Senior Quality Assurance Specialist at Chabre IT Services, you will play a key role in ensuring the quality and regulatory compliance of medical devices. Your responsibilities will include creating and maintaining quality management system procedures, monitoring and analyzing the effectiveness of the quality management system, and developing corrective actions and solutions.
Key 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 other 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
- Participate in the evaluation and approval of suppliers
- Provide quality and regulatory-related trainings
About Our Client:
Our client is a leading company in the medical laboratory testing sector, operating since 1992. They offer a wide range of diagnostic tests for patients, companies, and medical facilities. They have modern laboratories in various locations in Poland and work on improving medical equipment, providing online medical consultations, and managing patient test results.
Qualifications:
- Working knowledge as a Senior QA Engineer with contact with medical device regulatory or other regulated business
- Proven practical experience with medical device standards such as ISO 13485, ISO 14971, IEC 62304, and 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
We Offer:
- Rate to 160.00 PLN/h + VAT
- Remote work
- Subsidy for peripherals in the amount of 500.00 zł
- Working tool (MacBook Pro or Lenovo Legion 5)
- Co-financing of courses related to the position
- Benefits: MultiSport, Medicover
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