Quality Assurance Specialist
1 week ago
Job Responsibilities Quality Management System (QMS):
Implementing and maintaining a QMS (like ISO to ensure products meet quality, safety, and regulatory standards. Regulatory Compliance:
Identifying, interpreting, and ensuring adherence to relevant medical device regulations for market entry and ongoing compliance. Documentation Management:
Creating, reviewing, and controlling technical files, regulatory submissions (e.g., 510(k)), quality agreements, and internal procedures. Design Control & Development Support:
Providing QA/RA input and support for design and development activities to ensure compliance from the outset. Risk Management:
Participating in risk management activities throughout the product life cycle to identify and mitigate potential hazards. Post-Market Surveillance & Vigilance:
Monitoring device performance in the market, investigating customer complaints and non-conformity, and managing vigilance reporting. Supplier Management:
Supporting the management of supplier quality and compliance. Internal Audits & Process Improvement:
Conducting internal audits and leading initiatives to improve processes and ensure adherence to QMS requirements.
Key Skills & Qualifications
Regulatory Expertise: Deep knowledge of global medical device regulations and standards.
Problem-Solving & Attention to Detail: Crucial for interpreting regulations, documenting processes, and resolving issues.
Communication Skills: To coordinate with internal departments and external stakeholders.
Bachelor's Degree: In a relevant field such as engineering, life sciences, or a related technical discipline.
Experience: Previous experience in QA/RA within the medical device industry is an advantage.
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