Quality Engineer - Boston, United States - Katalyst Healthcares and Life Sciences

Katalyst Healthcares and Life Sciences Boston, United States

3 weeks ago

Description

Responsibilities:

Develop and implement quality management systems compliant with relevant regulatory standards (ISO 13485, FDA QSR, etc.) Conduct internal audits and inspections of all aspects of the quality system, including design, manufacturing, and distribution.

Investigate and analyze non-conformances, identify root causes, and implement corrective and preventive actions (CAPAs) Review and approve design documentation, including design controls, risk management plans, and quality plans.

Participate in design reviews and provide feedback on design for manufacturability and quality. Conduct product testing and validation to ensure compliance with design specifications and regulatory requirements. Manage and maintain quality records and documentation. Develop and maintain training programs for quality personnel. Stay up to date on the latest regulatory changes and best practices in medical device quality assurance. Contribute to continuous improvement initiatives to enhance the effectiveness and efficiency of the quality system.

Requirements:

Bachelor's degree in engineering, science, or a related field Minimum of 2 years of experience in medical device quality assurance Strong understanding of quality management systems (ISO 13485, FDA QSR) Experience with conducting audits and investigations Excellent analytical and problem-solving skills Strong communication and interpersonal skills Proficient in Microsoft Office Suite and quality management software bility to work independently and as part of a team.

Detail-oriented and highly organized Strong commitment to quality and patient safety

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