Quality Systems Analytics Specialist

1 week ago

Somerville, New Jersey, United States AbbVie Full time
Job Title: Quality Systems Analytics Specialist

AbbVie is seeking a skilled Quality Systems Analytics Specialist to join our team at the Branchburg site. This position offers a unique opportunity to lead and develop a data-driven culture within our quality organization and site, reporting directly to the Executive Director of quality.

Key Responsibilities:

  • Manage critical metrics for the Branchburg Quality organization, including Quality Index, Site Business Review, Quality Systems Management Review, and Post Market Surveillance Review.
  • Provide in-depth insights for each metric, understand the context and drivers for any misses, and represent Branchburg in above-site reviews when required.
  • Own and maintain procedures for Post Market Surveillance, Quality Management System Review, and other assigned procedures.
  • Understand the various systems that house quality data and records and extract data as needed, depending on the information required.
  • Lead the establishment of a metrics-driven culture across the organization, collaborating with key stakeholders to understand data sources, limitations, and opportunities for leveraging data.
  • Develop standard work, enhance knowledge and skills, and integrate metrics into tier structures to drive actions and share best practices.
  • Generate ad hoc reports, develop analytics tools, and use visualization/BI tools to create automated dashboards.
  • Collaborate cross-functionally to drive corrective actions to improve metrics. Ensure key metrics are integrated into Tier and monthly review processes.
  • Collaborate cross-functionally on complaint trend monitoring, evaluation, and investigation of signals and potential trends. Generate and maintain Post-Market Surveillance Plans and Periodic Safety Update Reports according to required timelines for medical devices.
  • Monitor and implement processes to ensure compliance with regulations and guidelines, including FDA 21CFR 1271 and 820, ISO 9001 and 13485, EU MDR, Health Canada regulations, AATB, and state regulations.

Requirements:

  • Bachelor's degree in Science, Business, Engineering, or related discipline, or equivalent work experience with 3 to 5 years of experience in Medical Device, Pharmaceutical, Human Tissue, or other regulated industries is required.
  • 3-5 years of experience in quality analysis, operations analysis, or other quality-related responsibilities.
  • Demonstrated knowledge in Quality Systems, Regulations, and Standards.
  • Data-driven with strong problem-solving skills and a focus on continuous improvement.
  • Excellent communication skills at all levels (written and verbal) and attention to detail.
  • Demonstrated proficiency with Minitab, Power BI, and Microsoft Office Suite, especially PowerPoint, and advanced Excel skills (Power Query, pivot tables, complex formulas, etc.) required.
  • Familiarity with business systems such as SAP and Global TrackWise is preferred.
  • Lean, Six Sigma training, and expertise are preferred.

Additional Information:

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our short-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

Salary: $91,500 - $173,500

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