Senior Quality Assurance Professional
2 weeks ago
Job Overview:
We are seeking a seasoned Quality Assurance Specialist to join our team. This critical role plays a pivotal part in ensuring the delivery of high-quality products that meet regulatory standards and customer expectations.
The ideal candidate will have in-depth knowledge of global medical device regulations and standards, as well as strong analytical and problem-solving skills.
- Main Responsibilities:
- Develop and implement a Quality Management System (QMS) to guarantee product quality, safety, and regulatory compliance.
- Collaborate with cross-functional teams to ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
- Create, review, and control technical files, regulatory submissions, quality agreements, and internal procedures.
- Provide QA/RA input and support for design and development activities to ensure compliance from the outset.
- Identify and mitigate potential hazards throughout the product life cycle.
- Monitor device performance in the market, investigate customer complaints, and manage vigilance reporting.
- Support the management of supplier quality and compliance.
- Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.
Required Skills and Qualifications:
- Deep knowledge of global medical device regulations and standards.
- Critical thinking and problem-solving skills for interpreting regulations and resolving issues.
- Effective communication skills for coordinating with internal departments and external stakeholders.
- Bachelor's Degree in a relevant field such as engineering, life sciences, or a related technical discipline.
- Prior experience in QA/RA within the medical device industry is an advantage.
About the Role:
This is a challenging yet rewarding opportunity for a dedicated professional who is passionate about delivering high-quality products and services. If you have a strong track record of success in a similar role and a commitment to excellence, we encourage you to apply.
What We Offer:
In addition to a competitive compensation package, we offer a dynamic and supportive work environment that fosters growth and development.
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