Quality Assurance Professional
2 days ago
We are seeking a Quality Assurance Professional to implement and maintain our Quality Management System ensuring products meet quality, safety, and regulatory standards.
- Regulatory Compliance: Ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
- Documentation Management: Create, review, and control technical files, regulatory submissions, quality agreements, and internal procedures.
- Design Control & Development Support: Provide QA/RA input and support for design and development activities to ensure compliance from the outset.
- Risk Management: Participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
- Post-Market Surveillance & Vigilance: Monitor device performance in the market, investigate customer complaints, and manage vigilance reporting.
- Supplier Management: Support the management of supplier quality and compliance.
- Internal Audits & Process Improvement: Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.
- 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: Coordinate with internal departments and external stakeholders.
- Bachelor's Degree: 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.
This role offers a unique opportunity to contribute to the development of our Quality Management System, ensuring the delivery of high-quality products that meet regulatory standards.
The ideal candidate will possess excellent communication skills, attention to detail, and a strong understanding of regulatory compliance.
We are committed to fostering a culture of continuous improvement, and this role will play a key part in driving process improvements and ensuring adherence to our Quality Management System.
If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.
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