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About CooperSurgical
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 www.coopersurgical.com.
Work location: Trumbull, CT (on-site), Livingston, NJ (on-site) or Remote in US (if not residing in NY-metro area)
Scope:
The Data Engineer Lead - PMS & 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.
Job Summary:
The Data Engineer Lead - PMS & 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 & process improvements within PMS & QA and supports CooperSurgical Complaint Management and other Quality areas by working in partnership with our Commercial, Operations (QA & Manufacturing), Regulatory Affairs and Post Market Surveillance teams.
Responsibilities

• Develop custom Power BI dashboards and data visualizations to monitor & continuously improve the Complaint Management process and ensure adherence to process requirements while driving process efficiencies.
• Lead Trending Process (owner); maintain trending procedures & data analysis validation in compliance with regulatory requirements, and lead 'front room' discussions for trending in Notified Body & other regulatory audits/inspections.
• Ensure compliance with CooperSurgical Quality System procedures and applicable external standards, including FDA, ISO 13485, MDSAP, EUMDR.
• Work directly with cross-functional teams to support complaint daily management activities and timely escalation of complaint trends.
• Work with Complaint Management leadership team to implement leading & lagging process indicators and develop complaint reports that address questions posed in relation to complaint management & KPIs.
• Develop & implement quarterly complaint trend review meetings.
• Navigate different ERP/QMS systems to extract data for analysis & trending.
• Work with various KPI owners to facilitate efficient & accurate data reporting to CooperSurgical leadership teams.
• Oversee data review for monitoring, trending & escalation of process indicators, ensuring data integrity of outputs by verification & validation activities.
• Lead data input needed to support critical post market documents (PSUR, SSCP, CER, etc).
• Develop training materials to aid teams with trending methods and analysis.
• Lead process improvement projects in other areas of CooperSurgical as needed (transition to new eQMS, etc).
• Perform other duties as assigned.

Travel: This position may require 5% domestic and/or foreign travel.
Qualifications
Knowledge, Skills and Abilities:

• 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 & effectively communicate key messages & insights to stakeholders.
• Ability to articulate technical challenges/solutions with IT and key internal & external stakeholders.
• Knowledge of eQMS software (e.g. Trackwise, Veeva) and understanding build requirements when converting to new eQMS.
• Ability to develop, report & track KPIs and effectively communicate data-driven presentations/results to Post Market Surveillance, QA, Commercial and Executive Leadership teams.
• Knowledge of regulated environments & requirements, such as FDA Quality System Regulations, 21 CFR Part 820, MDD/MDR, and international standards (ISO 13485, ISO 14971, IEC 62304, etc).
• Demonstrate customer-focused mindset for all internal & external interactions.

Work Environment:

• Prolonged periods of sitting, especially in front of a computer.

Experience:

• 6+ years experience in medical device and/or pharmaceutical industries. (medical device industry experience preferred)
• 4+ 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)

Education:

• Bachelor's degree in mathematics, statistics, data analytics, engineering or relevant field is required. Certification in statistical techniques preferred.

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Our Benefits:
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 www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
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.
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.
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $120,000.00 - $160,000.00 annually. The actual base pay 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.