Corporate Qa/Ra Specialist

OBJECTIVE
Maintaining and improving our quality management system while ensuring compliance with regulatory requirements. 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.).

KEY QUALIFICATIONS AND EXPERIENCE

A bachelor's degree in a relevant scientific or engineering field (e.g., biology, chemistry, or biomedical engineering).

Ideally, 2-3 years experience.

OTHER SKILLS

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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