{"id":2235,"date":"2024-06-18T04:48:37","date_gmt":"2024-06-18T04:48:37","guid":{"rendered":"https:\/\/lamed.healthcare\/?post_type=current-opening&#038;p=2235"},"modified":"2024-11-17T10:56:26","modified_gmt":"2024-11-17T10:56:26","slug":"executive-quality-assurance","status":"publish","type":"current-opening","link":"https:\/\/nextstep.net.in\/lamed\/current-openings\/executive-quality-assurance\/","title":{"rendered":"MANAGER -QUALITY ASSURANCE"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>1. Regulatory Compliance:<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&nbsp;Ensure that products meet all regulatory requirements and maintain relevant documentation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. Quality Assurance:<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&nbsp;Develop and implement quality assurance processes and procedures.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Conduct internal audits and assessments to identify areas for improvement.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Collaborate with production teams to establish quality control measures.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. Documentation Management:<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Maintain and organize regulatory and quality documentation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Prepare and submit regulatory filings, such as 510(k) submissions or CE Mark applications.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Create and update technical files and product documentation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4. Compliance Audits:<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Coordinate and participate in regulatory audits and inspections.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Address findings and implement corrective and preventive actions (CAPA) as needed.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>5. Risk Management:<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Access and manage product risks in accordance with applicable standards.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Develop and maintain risk management files and reports.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6. Cross-Functional Collaboration:<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Collaborate with R&amp;D, manufacturing, and clinical teams to ensure alignment with quality and regulatory requirements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Provide regulatory guidance during product development and changes.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>7. Post-Market Surveillance:<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&nbsp;Monitor and report adverse events or non-compliance issues.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Educational Qualifications &amp; Experience:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Bachelor\u2019s degree in a Science or B.Pharma\/M.Pharma or Biomedical Engineering or Diploma in Regulator Affairs, Quality Management System.<\/li>\n\n\n\n<li>6+ years of experience in Quality Assurance and Regulatory Affairs.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Knowledge of medical device regulations and quality standards (e.g.- FDA 21 CFR Part 820, ISO 13485)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>1. Regulatory Compliance: Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking). &nbsp;Ensure that products meet all regulatory requirements and maintain relevant documentation. 2. Quality Assurance: &nbsp;Develop and implement quality assurance processes and procedures. Conduct internal audits and assessments to identify areas for improvement. Collaborate with production teams to establish [&hellip;]<\/p>\n","protected":false},"featured_media":0,"parent":0,"menu_order":0,"template":"","class_list":["post-2235","current-opening","type-current-opening","status-publish","hentry","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MANAGER -QUALITY ASSURANCE - La-med Healthcare<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nextstep.net.in\/lamed\/current-openings\/executive-quality-assurance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MANAGER -QUALITY ASSURANCE - La-med Healthcare\" \/>\n<meta property=\"og:description\" content=\"1. Regulatory Compliance: Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking). &nbsp;Ensure that products meet all regulatory requirements and maintain relevant documentation. 2. Quality Assurance: &nbsp;Develop and implement quality assurance processes and procedures. Conduct internal audits and assessments to identify areas for improvement. 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Regulatory Compliance: Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking). &nbsp;Ensure that products meet all regulatory requirements and maintain relevant documentation. 2. Quality Assurance: &nbsp;Develop and implement quality assurance processes and procedures. Conduct internal audits and assessments to identify areas for improvement. 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