
Product Quality Manager
1 day ago
We are seeking a highly skilled Quality Assurance Specialist to support the effective implementation of our Quality Management System (QMS).
Key Responsibilities:
- Develop and maintain QMS processes to ensure products meet quality, safety, and regulatory standards.
- Ensure compliance with relevant medical device regulations for market entry and ongoing adherence.
- 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 guarantee compliance from inception.
- Participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
- Monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting.
- Support the management of supplier quality and compliance.
- Conduct internal audits and lead initiatives to enhance processes and ensure adherence to QMS requirements.
Required Skills & Qualifications:
- Extensive knowledge of global medical device regulations and standards.
- Excellent analytical and attention to detail skills.
- Strong 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 advantageous.
Benefits:
A dynamic work environment and opportunities for professional growth.
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