- 경험
- 5년 이상
- 샐러리
- —
- 채용 공고
- 1
- 게시됨
- 3주 전
- 작업 모드
- 사무실에서
- 교육
- Degree in Engineering, Life Sciences, Health Sciences, Quality, or related discipline
- 적임
- Applicants with a relevant degree and at least 5 years’ experience in quality systems, quality assurance, or compliance within medical devices, especially those with startup, SaMD, regulatory, or validation experience, are suitable for this role.
- 재개하다
- 신청 시 필수 사항
당신이 일하게 될 곳
직무 설명
Overview
An innovative Cork-based startup in the advanced life sciences space is looking for a Quality Systems Manager to build, roll out, and maintain its Quality Management System (QMS) in line with the company’s strategic timeline. The business is developing a breakthrough AI-enabled healthcare product, and this role will be central to establishing a robust quality and compliance foundation.
Quality Management System
- Set up, implement, and continuously maintain the company’s QMS in accordance with ISO 13485.
- Own quality processes such as document control, CAPA, change management, training records, supplier oversight, and non-conformance handling.
- Keep quality documents and records accurate, current, and well organised.
- Assist with both internal and external audit activities.
- Promote and lead ongoing improvement initiatives across the organisation.
Design Controls and Product Development
- Help put design control procedures into practice.
- Manage the Design History File (DHF) and related supporting documentation.
- Ensure clear traceability from requirements through risk, verification, validation, and clinical evidence.
- Partner with clinical, research, and software teams to embed quality practices throughout development work.
Risk Management and Compliance
- Support risk management work aligned with ISO 14971.
- Maintain risk files, hazard analyses, and risk assessments.
- Ensure quality and compliance expectations are built into product development activities.
- Contribute to validation and documentation for software and AI-based systems.
Regulatory Support
- Collaborate with external regulatory consultants on regulatory strategy and submissions.
- Prepare and keep up-to-date the documentation needed for regulatory reviews and filings.
- Carry out actions resulting from regulatory guidance and gap analysis.
- Track and maintain compliance documentation required for regulatory readiness.
Requirements
- A degree in Engineering, Life Sciences, Health Sciences, Quality, or a closely related field.
- At least 5 years of experience in quality assurance, quality systems, or compliance within medical devices.
- Hands-on experience implementing or maintaining QMS processes in a startup setting.
- Strong knowledge of ISO 13485.
- Practical experience with document control, CAPA, audits, and broader quality processes.
- Background supporting risk management activities.
- Excellent organisational, communication, and documentation abilities.
- Confidence working independently in a fast-moving startup environment.
- Experience in medical devices or Software as a Medical Device (SaMD).
- Working knowledge of ISO 14971 and IEC 62304.
- Exposure to regulatory submissions or regulatory readiness work.
- Experience developing or scaling a QMS in an early-stage company.
- PRRC experience.
- Familiarity with software.
- Experience supporting clinical studies or validation projects.
- Understanding of EU MDR and/or FDA medical device requirements.
- Knowledge of the EU AI Act.
Additional Information
This position is based onsite in the Cork Metropolitan Area. The role is full-time. No salary details, vacancy count, or start date were provided.