Quality Assurance Professional
2 days ago
Job Opportunity
We are seeking a dedicated professional to implement and maintain a quality management system (QMS) that ensures products meet quality, safety, and regulatory standards.
- Regulatory Compliance: Identify, interpret, and 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 non-conformity, 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.
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.
Why This Role Matters
This position plays a critical role in ensuring the quality and safety of our products. If you have a passion for regulatory compliance and quality assurance, we encourage you to apply.
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