Quality Assurance Specialist
Description:
The Quality Assurance Specialist will take ownership of ensuring robust quality systems are in place to support both internal manufacturing and external supply chain operations. This role is central to maintaining compliance with ISO 13485, FDA 21 CFR 820, and other applicable regulations.
1. Maintain and evolve the Quality Management System (QMS) to ensure continuous improvement across all quality processes.
2. Oversee all quality aspects of internal manufacturing operations, including batch release, in-process controls, and product inspections.
3. Provide quality oversight for subcontract manufacturing partners, including audits, quality agreements, and supplier performance management.
4. Lead internal and external audits, manage CAPAs, and ensure alignment across compliance and submission activities.
5. Support internal R&D, engineering, and operations teams with quality input during project development and tech transfer.
6. Act as the quality lead for product lifecycle activities from development through commercialization.
7. Work closely with regulatory affairs to ensure seamless integration across compliance and submission activities.
Responsibilities:
* Promote a culture of quality within the organization.
* Identify and mitigate risks associated with non-compliance.
* Develop and implement process improvements.
* Collaborate with cross-functional teams to achieve quality objectives.
Requirements:
* Bachelor's degree in a relevant field (e.g., engineering, life sciences).
* Minimum 3 years of experience in quality assurance or a related field.
* Strong understanding of ISO 13485, FDA 21 CFR 820, and other applicable regulations.
* Excellent communication and leadership skills.
What We Offer:
* A competitive salary and benefits package.
* Opportunities for professional growth and development.
* A collaborative and dynamic work environment.