Senior Quality Assurance Specialist
Posted 22 days ago · 82 applicants
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The role in plain words
This role supports quality activities across the entire product lifecycle, including development, manufacturing transfer, and ongoing operations. The specialist will maintain Quality Management System processes, review quality documentation, and collaborate with cross-functional teams to ensure compliance with medical device regulations.
- 5+ years of experience in Quality Assurance
- BSc in a relevant scientific or engineering discipline
- Familiarity with medical device quality processes, including risk management, design controls, validation activities, and manufacturing-related quality processes
- Strong written and verbal communication skills in English
- High attention to detail and strong organizational skills
- Experience with change control processes and quality documentation
- Hebrew language skills
Extracted from the job description · kept up to date automatically
Who this suits
This role suits professionals with at least 5 years of quality assurance experience in the medical device industry and a relevant scientific or engineering degree. It is less ideal for those without a background in medical device regulations like ISO 13485.
Full job description
Original listing · kept for referencePi-Cardia, a dynamic medical device startup specializing in cardiovascular innovations, is looking for an experienced Senior Quality Assurance Specialist to join our growing team. This role supports quality activities across product development, manufacturing transfer, and ongoing operations, and contributes to maintaining a robust and compliant Quality Management System.
Responsibilities
• Support and maintain Quality Management System (QMS) processes in accordance with applicable regulations and standards.
• Contribute to quality activities across the product lifecycle, including development, manufacturing-related processes, validation activities, and change management processes.
• Participate in the preparation, review, and maintenance of quality documentation such as procedures, work instructions, protocols, reports, and quality records.
• Collaborate with cross-functional teams to support quality objectives, process improvements, manufacturing changes, and continuous improvement initiatives.
• Support implementation, documentation, and follow-up of validation and quality-related change activities as required.
• Support compliance with regulatory and quality standards, including ISO 13485 and applicable medical device regulations.
• Participate in internal and external audits as needed.
Requirements:
• 5+ years of experience in Quality Assurance within the medical device industry.
• BSc in a relevant scientific or engineering discipline.
• Familiarity with medical device quality processes, including risk management, design controls, validation activities, and manufacturing-related quality processes.
• Experience with change control processes and quality documentation- an advantage.
• Strong written and verbal communication skills in English; Hebrew is an advantage.
• High attention to detail and strong organizational skills.
• Ability to work both independently and as part of a team in a dynamic environment.
Questions about this role
- This listing did not state a salary. We only show pay when the employer publishes it.
- 5+ years of experience in Quality Assurance, BSc in a relevant scientific or engineering discipline, Familiarity with medical device quality processes, including risk management, design controls, validation activities, and manufacturing-related quality processes, Strong written and verbal communication skills in English, High attention to detail and strong organizational skills