Quality Assurance Expert
2 days ago
The role of Quality Assurance Expert is a crucial position in ensuring the quality and safety of products. As part of our team, you will be responsible for implementing and maintaining a Quality Management System (QMS) that meets the required standards.
Key Responsibilities include:
- Developing and implementing a QMS to ensure products meet quality, safety, and regulatory standards.
- Interpreting and ensuring adherence to relevant medical device regulations for market entry and ongoing compliance.
- Creating, reviewing, and controlling technical files, regulatory submissions, quality agreements, and internal procedures.
- Providing QA/RA input and support for design and development activities to ensure compliance from the outset.
- Participating in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
- Monitoring device performance in the market, investigating customer complaints and non-conformity, and managing vigilance reporting.
- Supporting the management of supplier quality and compliance.
- Conducting internal audits and leading initiatives to improve processes and ensure adherence to QMS requirements.
Required Skills and Qualifications include:
- Deep knowledge of global medical device regulations and standards.
- Problem-solving and attention to detail are crucial for interpreting regulations, documenting processes, and resolving issues.
- Effective 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.
- Previous experience in QA/RA within the medical device industry is an advantage.
This position offers a competitive compensation package including salary, benefits, and opportunities for professional growth and development. 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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