Job Overview:
We are seeking a senior quality engineer to lead the implementation and maintenance of our Quality Management System (QMS), focusing on continuous improvement.
* Drive QMS strategy and ensure overall quality excellence is delivered.
* Collaborate with cross-functional teams to plan, execute, and document QA activities.
* Develop and review test specifications, part specifications, and design specifications.
* Support manufacturing team activities in a regulated environment.
* Provide practical QA and Design Assurance expertise.
Key Responsibilities:
1. Implement and maintain QMS processes.
2. Evaluate company compliance with regulatory requirements.
3. Develop and review test specifications.
4. Assist manufacturing team activities.
5. Offer QA and Design Assurance guidance.
6. Cultivate relationships with supply chain for supplier-related activities.
7. Coordinate key activities such as internal audits and complaint processes.
Required Qualifications:
* Bachelor's Degree in Engineering, Science, or related field.
* At least 3 years' experience in medical device quality/design assurance role.
* Recent regulatory experience including FDA regulations and ISO 13485.
* Possess a Master's degree in Engineering, Science, or related field.
* Experience in implantable medical devices.
Reporting Structure:
This role reports directly to the Quality Systems Manager.