Data Engineer Lead- PMS & QA

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    "ShortDescriptionStr": "About CooperSurgical\n\nCooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. \n\nWork location: Trumbull, CT (on-site), Livingston, NJ (on-site) or Remote in US (if not residing in NY-metro area)",
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    "ExternalDescriptionStr": "<p class=\"elementtoproof\"><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\"><strong>About CooperSurgical</strong></span></span></p><p style=\"background-color: white; margin-bottom: 0in;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at&nbsp;</span></span><a href=\"http://www.coopersurgical.com\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">www.coopersurgical.com</span></span></a><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">.&nbsp;</span></span></p><p style=\"margin: 0in;\">&nbsp;</p><p><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\"><strong>Work location:</strong> Trumbull, CT (on-site), Livingston, NJ (on-site) or Remote in US (if not residing in NY-metro area)</span></span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Scope:&nbsp;</strong></span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"color: black; font-family: Arial, sans-serif;\">The Data Engineer Lead - PMS &amp; QA leads data analysis, visualization, and reporting of Medical Device performance and Post Market Surveillance activities within the PMS team as well as the broader QA function and supports CooperSurgical Complaint Management and other Quality areas by working in partnership with Commercial, Operations, Regulatory Affairs and Post Market Surveillance teams.&nbsp;</span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Job Summary:</strong></span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"color: black; font-family: Arial, sans-serif;\">The Data Engineer Lead - PMS &amp; QA is responsible for leading data analysis, visualization, and reporting of Medical Device performance and Post Market Surveillance activities within the PMS team as well as across the broader QA function. This role helps to ensure on-going regulatory compliance and continuous product &amp; process improvements within PMS &amp; QA and supports CooperSurgical Complaint Management and other Quality areas by working in partnership with our Commercial, Operations (QA &amp; Manufacturing), Regulatory Affairs and Post Market Surveillance teams.&nbsp;</span></p>",
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    "ExternalQualificationsStr": "<p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Knowledge, Skills and Abilities:</strong></span></p><ul style=\"list-style-type: disc;\"><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Knowledge of applied statistics and coding, ability to interact with various databases to build custom extracts of data into Power BI (expert) and other data visualization platforms to clearly &amp; effectively communicate key messages &amp; insights to stakeholders.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Ability to articulate technical challenges/solutions with IT and key internal &amp; external stakeholders.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Knowledge of eQMS software (e.g. Trackwise, Veeva) and understanding build requirements when converting to new eQMS.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Ability to develop, report &amp; track KPIs and effectively communicate data-driven presentations/results to Post Market Surveillance, QA, Commercial&nbsp;and Executive Leadership teams.&nbsp;</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Knowledge of regulated environments &amp; requirements, such as FDA Quality System Regulations, 21 CFR Part 820, MDD/MDR, and international standards (ISO 13485, ISO 14971, IEC 62304, etc).&nbsp;&nbsp;</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Demonstrate customer-focused mindset&nbsp;for all internal &amp; external interactions.</span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Work Environment:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Prolonged periods of sitting, especially in front of a computer.</span></span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Experience:</strong></span></p><ul style=\"list-style-type: disc;\"><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">6+</span><span style=\"color: red; font-family: Arial, sans-serif;\">&nbsp;</span><span style=\"font-family: Arial, sans-serif;\">years experience in medical device and/or pharmaceutical industries.&nbsp;(medical device industry experience preferred)</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">4+</span><span style=\"color: red; font-family: Arial, sans-serif;\">&nbsp;</span><span style=\"font-family: Arial, sans-serif;\">years experience working with data analytics, coding, evaluating trending data, and drawing insights to make strategic decisions. (specific experience with complaint data analytics in the medical device industry preferred)</span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Education:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\">Bachelor's degree in mathematics, statistics, data analytics, engineering or relevant field is required. Certification in statistical techniques preferred.</span></li></ul><p>&nbsp;</p><p><span style=\"font-family: Arial, sans-serif;\">#LI-KA1</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><strong>Our Benefits:</strong></span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at&nbsp;</span><a href=\"https://www.coopersurgical.com/\" target=\"_blank\" title=\"https://www.coopersurgical.com/\"><span style=\"color: rgb(0, 135, 204); font-family: Arial, sans-serif;\">www.coopersurgical.com</span></a><span style=\"color: black; font-family: Arial, sans-serif;\">&nbsp;to learn more about CooperSurgical and the benefits of becoming a member of our team.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">For U.S. locations that require disclosure of compensation, the starting base pay&nbsp;for this role is between&nbsp;$120,000.00 - $160,000.00 annually. The&nbsp;actual base pay&nbsp;includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.</span></span></p>",
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(specific experience with complaint data analytics in the medical device industry preferred)</span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Education:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\">Bachelor's degree in mathematics, statistics, data analytics, engineering or relevant field is required. Certification in statistical techniques preferred.</span></li></ul><p>&nbsp;</p><p><span style=\"font-family: Arial, sans-serif;\">#LI-KA1</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><strong>Our Benefits:</strong></span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at&nbsp;</span><a href=\"https://www.coopersurgical.com/\" target=\"_blank\" title=\"https://www.coopersurgical.com/\"><span style=\"color: rgb(0, 135, 204); font-family: Arial, sans-serif;\">www.coopersurgical.com</span></a><span style=\"color: black; font-family: Arial, sans-serif;\">&nbsp;to learn more about CooperSurgical and the benefits of becoming a member of our team.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">For U.S. locations that require disclosure of compensation, the starting base pay&nbsp;for this role is between&nbsp;$120,000.00 - $160,000.00 annually. The&nbsp;actual base pay&nbsp;includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.</span></span></p>",
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    "ExternalResponsibilitiesStr": "<ul style=\"list-style-type: disc;\"><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Develop custom Power BI dashboards and data visualizations to monitor &amp; continuously improve the Complaint Management process and ensure adherence to process requirements while driving process efficiencies.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Lead Trending Process (owner); maintain trending procedures &amp; data analysis validation in compliance with regulatory requirements, and lead ‘front room’ discussions for trending in Notified Body &amp; other regulatory audits/inspections.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Ensure compliance with CooperSurgical Quality System procedures and applicable external standards, including FDA, ISO 13485, MDSAP, EUMDR.&nbsp;</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Work directly with cross-functional teams to support complaint daily management activities and timely escalation of complaint trends.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Work with Complaint Management leadership team to implement leading &amp; lagging process indicators and develop complaint reports that address questions posed in relation to complaint management &amp; KPIs.</span><span style=\"color: red; font-family: Arial, sans-serif;\">&nbsp;</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Develop &amp; implement quarterly complaint trend review meetings.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Navigate different ERP/QMS systems to extract data for analysis &amp; trending.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Work with various KPI owners to facilitate efficient &amp; accurate data reporting to CooperSurgical leadership teams.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Oversee data review for monitoring,&nbsp;trending &amp; escalation of process indicators, ensuring data integrity of outputs by verification &amp; validation activities.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Lead data input needed to support critical post market documents (PSUR, SSCP, CER, etc).</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Develop training materials to aid teams with trending methods and analysis.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Lead process improvement projects in other areas of CooperSurgical as needed (transition to new eQMS, etc).</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Perform other duties as assigned.</span></li></ul><p style=\"margin-left: 0.25in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Travel:</strong> </span><span style=\"color: black; font-family: Arial, sans-serif;\">This position may require 5% domestic and/or foreign travel.&nbsp;</span></p>",
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