Senior Quality Assurance Specialist
4 days ago
We are seeking a Senior Quality Engineer to provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes.
Key Responsibilities- Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers.
- Ensure compliance with regulations and standards.
- Previous industry experience is desired.
- Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) is also desirable.
- Understanding of US and International Medical Device Regulations is necessary.
- Familiarity with ISO 13485, GDP, GMP is preferred.
- Strong knowledge of Quality Concepts such as Risk Management, CAPA, Audits, Statistics is required.
- The successful candidate must possess strong communication, project management, and influencing skills, with the ability to manage multiple tasks simultaneously.
- Ability to represent the Quality function within project teams.
- Strong interpersonal, written, and oral communication and negotiation skills.
- Strong critical thinking and outside the box thinking.
- Highly developed problem-solving and analytical skills.
- Ability to work independently and as part of cross-functional teams.
- Experience working in a compliance risk environment.
- Computer literacy is required.
- Some travel may be required.
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