Understand and apply FDA CFR 820, ISO 13485, ISO 14971, Canadian, Japanese, Brazilian and European medical device regulations. Provide quality engineer support to ensure that products are manufactured with a high level of quality, while being in compliance with standards and regulations governing medical device manufacturing. Administer and manage delivery holds and reconciliations for assigned product lines. Provide support for field actions as needed. Develop, review and approve procedures, technical/validation reports, change notices, risk assessments, and other related quality system documentation. Lead, support, or facilitate investigations, CAPAs, process changes, quality plans and other Quality activities. Lead or support internal and external quality system audits. Drive resolution of nonconformities.
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