Product Safety and Compliance Specialist
1 week ago
This position is responsible for ensuring product quality, safety, and effectiveness. The Quality Assurance Engineer will work closely with project teams to establish quality documentation, provide detailed planning for pilot production and scale-up plans in New Product Introduction programs.
- Develop and implement quality systems and processes that ensure compliance with regulatory requirements.
- Conduct risk assessments of the design to determine ability to function as intended.
- Responsible for timely Corrective and Preventative Actions (CAPA), change control, internal and vendor audits, product release, document control, and design history files.
- Communicate effectively with customers and suppliers to ensure ongoing exchange of information.
The ideal candidate will have a strong understanding of medical device regulations and ISO 13485. They should be able to lead product verification & validation activities and have experience working in a dynamic environment.
Key qualifications include:
- Minimum Bachelor's degree in Engineering or related field.
- 3 years of medical device design and development/quality assurance experience required.
- Ability to lead product verification & validation activities.
- Familiarity with FDA QSRs and medical device regulations.
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