<p>Are you passionate about ensuring the highest standards of quality and compliance in the medical device industry? We are seeking a dedicated and dynamic Clinical QA Specialist to join our team onsite in Newark, DE! In this pivotal role, you will be responsible for the timely and thorough investigation and reporting of Potential Adverse Events, Adverse Events, and other regulatory reporting required due to complaints analysis. You will work closely with Technical Service, Marketing, Sales, Legal, and potentially Customers, fostering seamless communication and collaboration. This role requires your presence onsite, allowing you to make a tangible impact and drive excellence in our operations. Apply today!</p> <p>Knowledge:</p> <ul> <li>In-depth understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 standards. </li><li>Familiarity with medical procedures and expected outcomes related to the portfolio of products. </li><li>Knowledge of complaint handling, post-market surveillance processes, and regulatory reporting requirements. </li></ul> <p>Skills:</p> <ul> <li>Strong analytical and investigative skills to assess adverse events and identify next steps. </li><li>Exceptional verbal and written communication skills to collaborate with internal teams, regulatory bodies, and external stakeholders. </li><li>Proficiency in managing and innovating processes to improve compliance and efficiency in post-market surveillance. </li><li>Ability to work independently while meeting deadlines in a fast-paced environment. </li><li>Adept in handling metrics, indicators, and quality reports related to reportable events. </li></ul> <p>Behaviors:</p> <ul> <li>High attention to detail and a commitment to accuracy in reporting and documentation. </li><li>Proactive mindset with a focus on continuous improvement and innovation. </li><li>Collaborative and team-oriented approach to problem-solving. </li><li>Resilient and adaptable, thriving under pressure and regulatory scrutiny. </li><li>Ethical and customer-focused, ensuring patient safety is the top priority. </li></ul> <p>Experience:</p> <ul> <li>A minimum of 5 years' experience in a similar role involving post-market surveillance, adverse event reporting, and regulatory compliance. </li><li>Hands-on experience working with cross-functional teams such as Technical Service, Marketing, Sales, and Legal. </li><li>Track record of successful participation in internal and external audits, as well as regulatory agency interactions. </li><li>Experience in executing investigations like CAPAs, NCEs, and IACAs to resolution. </li></ul> <p>The individual fulfilling this role must possess the physical capability to sit for extended periods, handle, or manipulate objects, tools, or controls with precision. Additionally, they should be able to stand, walk, reach with hands and arms, stoop, kneel, crouch, and be prepared to engage in domestic and international travel as required by the position.</p> <p>Why join Hologic?</p> <p>We are committed to making Hologic the destination for top talent. 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> <p>The annualized base salary range for this role is $83,000 - $129,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.</p> <p>Agency and Third-Party Recruiter Notice</p> <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. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.</p> <p>Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.</p> <p>#LI-NT1</p>