Quality Assurance Specialist Role
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This is a key contributor position in ensuring the quality and compliance of medical devices and life sciences products. It involves developing and executing robust Quality Control processes and adhering to regulatory standards, particularly ISO 13485.
The role entails implementing Quality Management Systems (QMS), conducting internal audits, and supporting external audits to maintain certifications. Additionally, it involves managing Corrective and Preventive Actions (CAPAs) and contributing to continuous improvement initiatives.
Key Responsibilities:
* Develop and execute Quality Assurance and Quality Control processes to ensure compliance with regulatory standards for medical devices (Class I/II/III).
* Conduct internal audits and support external audits to maintain ISO 13485 and other relevant ISO certifications.
* Manage CAPAs and contribute to continuous improvement initiatives.
* Collaborate with R&D, manufacturing, and regulatory teams to ensure quality standards are met throughout the product lifecycle.
* Maintain and improve QMS, with familiarity in tools like Greenlight Guru being advantageous.
* Support documentation, risk management, and validation activities in line with ISO standards and regulatory requirements.
Required Qualifications:
* Bachelor's degree in Engineering, Life Sciences, or a related field.
* Advanced degrees or certifications (e.g., CQE) are a plus.
* 3+ years of experience in Quality Assurance or Quality Control within the medical device or life sciences industry.
* Strong knowledge of ISO 13485, with additional experience in ISO 9001 or other relevant standards being beneficial.
* Excellent problem-solving skills and attention to detail, with fluent English communication skills for cross-functional collaboration.
Benefits:
* Fast-paced and innovative work environment.
* Opportunities for professional growth and development.
* Collaborative team dynamics.