Quality Specialist - Product Complaints

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    "ExternalDescriptionStr": "<div style=\"font-style:normal; font-weight:400; margin:0px; padding:0px\">\n <div style=\"margin:0px; padding:0px\">\n  <p><strong>The Post-Market QA Specialist</strong> plays a key role in ensuring the safety, effectiveness, and regulatory compliance of Hologic’s on-market molecular diagnostic products. The ideal candidate will be responsible for monitoring and facilitating the handling of post-market complaints as well as ensuring compliance with applicable industry regulations, standards, and company policy. The role may support product complaint investigations, including lab testing, risk assessment and root cause analysis across Hologic’s global molecular diagnostic product lines.&nbsp;</p>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <p><strong>ESSENTIAL DUTIES AND RESPONSIBILITIES</strong>&nbsp;</p>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <p>The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.&nbsp;</p>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>&nbsp;Complaint Handling and Investigation:&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Receive, document, and process product complaints in compliance with Hologic SOPs and applicable regulatory requirements (FDA, ISO, EU MDR).&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Conduct initial assessments of complaints and work with cross-functional teams as needed to support timely investigation, root cause analysis, and resolution of complaints of moderate complexity&nbsp;&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Ensure timely, accurate, and complete complaint records in the complaint management system&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>May support product complaint investigations, including lab testing, risk assessment, and root cause analysis as needed.&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Regulatory Reporting:&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Identify and escalate potential adverse events to QA management.&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Support preparation and submission of regulatory reports (e.g., FDA MDR, EU Vigilance, FSCA/FSN) according to global regulatory requirements&nbsp;&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Ensure post-market activities are compliant with Hologic’s quality system and all applicable standards&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Data Analysis &amp; Trending:&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Sustain routine monitoring and trending of product performance, complaint data, adverse event reporting data, and quality KPI’s to identify and track potential product issues&nbsp;&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Audit &amp; Inspection Support:&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Support internal and external audits related to post-market surveillance and complaint handling as needed&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Maintain accurate and audit-ready documentation.&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Training &amp; Process Development:&nbsp;</li>\n  </ul>\n </div>\n</div>\n<div style=\"font-style:normal; font-weight:400; margin:0px; padding:0px\">\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Contribute to the development and improvement of processes, SOPs, work instructions, and training materials related to post-market quality assurance&nbsp;&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Train others as needed&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <p>&nbsp;</p>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <p><strong>KNOWLEDGE&nbsp;</strong></p>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Quality Systems:&nbsp; Working knowledge of post-market surveillance, complaint handling, risk management, and non-conformance &nbsp;/ CAPA processes&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Compliance:&nbsp; Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and global post-market surveillance requirements&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Data Trending:&nbsp; Basic knowledge of tracking and trending product / process metrics and KPI’s with statistical methods and data visualization tools (e.g., Power BI), ideally for manufacturing or technical support of high volume products&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Product Knowledge:&nbsp; Familiarity with processes and practices related to the design and manufacturing of in vitro diagnostic or medical device products, ideally with high volume automated reagent / hardware systems&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <p>&nbsp;<strong>SKILLS&nbsp;</strong></p>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Communication: aptitude to clearly explain data, processes, compliance requirements to cross-functional audiences in meetings, presentations, and reports&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Organization: skilled at planning, executing, and managing tasks and processes to drive action individually and with others in a team setting&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Data Analysis: aptitude to compile, research, and critically evaluate data to identify and understand patterns / trends as well as make informed conclusions&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <p><strong>BEHAVIORS&nbsp;</strong></p>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Detail Oriented: proactively identifies and focuses on critical details needed to ensure accurate and high-quality results&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Inquisitive: strong intellectual desire to understand and address technical issues by seeking information through asking probing questions, research, data analysis, and collaboration with others&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Quality / Safety Focused: committed to ensuring product quality and safety by making and documenting objective conclusions based on data and facts&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Resourceful: applies self-directed research, problem solving, critical thinking, collaboration skills to approach uncertainty and adapt to change&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <p><strong>REQUIREMENTS&nbsp;</strong></p>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>B.S. in scientific or engineering discipline&nbsp;</li>\n  </ul>\n </div>\n</div>\n<div style=\"font-style:normal; font-weight:400; margin:0px; padding:0px\">\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>3+ years of experience in a quality role within an ISO 13485 quality management system, ideally with focus on Post-Market Surveillance, complaint handling, and / or complaint trending.&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <ul>\n   <li>Prior experience supporting development and / or manufacturing of IVD or other medical device products preferred&nbsp;</li>\n  </ul>\n </div>\n <div style=\"margin:0px; padding:0px\">\n  <p>&nbsp;</p>\n  <p>The annualized base salary range for this role is $71,000 - $104,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.</p>\n  <p><strong>Why Hologic?</strong></p>\n  <p>We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.</p>\n  <p>If you have the right skills and experience,<strong> apply today!</strong></p>\n  <p>#LI-AV1</p>\n  <p>Agency and Third Party Recruiter Notice:</p>\n  <p>Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.&nbsp; All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.</p>\n  <p>Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.</p>\n </div>\n</div>",
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