Quality Assurance Specialist

hace 6 días

Barcelona, Barcelona, España Sensofar A tiempo completo
{"h1": "Corporate Qa/Ra Specialist", "p": "At Sensofar, we are committed to maintaining and improving our quality management system while ensuring compliance with regulatory requirements. As a Corporate Qa/Ra Specialist, you will collaborate closely with cross-functional teams to implement and uphold quality standards throughout the product lifecycle.

Responsibilities:

* Develop and maintain quality management system (QMS) documentation, including policies, procedures, and work instructions, in compliance with applicable regulatory standards (ISO 9001, ISO 13485, FDA).
* Conduct internal audits to assess compliance with QMS requirements and identify areas for improvement.
* Coordinate external audits by regulatory agencies and notified bodies and assist in addressing audit findings and implementing corrective actions.
* Review product documentation, including design control documents, technical files, and labeling, to ensure regulatory compliance.
* Support new product development by providing regulatory guidance and ensuring adherence to quality requirements.
* Participate in risk management activities, including hazard analysis, risk assessments, and mitigation strategies.
* Assist in reviewing and resolving nonconformances, deviations, and complaints, ensuring timely investigation and corrective actions.
* Stay abreast of regulatory changes and industry best practices to inform continuous improvement initiatives.
* Prepare and maintain the system's post-sales documentation (Site Acceptance, Installation Qualification, Calibration certificates, etc.).

Requirements:

* A bachelor's degree in a relevant scientific or engineering field (e.g., biology, chemistry, or biomedical engineering).
* Ideally, 2-3 years experience.
* Understanding of regulatory requirements and quality standards, such as FDA regulations (e.g., 21 CFR Part 820) and ISO 13485.
* Experience with QMS implementation and maintenance, including document control, training, and audit management.
* Excellent communication and interpersonal skills, with the ability to collaborate effectively across functional teams.
* Detail-oriented with strong analytical and problem-solving abilities.
* Excellent English verbal and written communication skills.
"}

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