Quality Assurance Specialist

Job Responsibilities Quality Management System (QMS):

Implementing and maintaining a QMS (like ISO 13485) 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.