Quality Engineer, Analytics
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Under the direction of the Director of Quality Engineering and Analytics, the Quality Engineering Specialist is responsible for providing leadership to global projects in post market quality to ensure that compliance and business objectives are met. This includes the use of business intelligence platforms to create and display analytic tools to efficiently drive quality improvement across the organization. Specifically, the Quality Engineering Specialist will be responsible for:
- Ensuring consistent global post-marketing trending strategies across the Allergan network of sites.
- Providing validated/verified data analysis tools to monitor post-marketing performance of our medical device, pharmaceutical, combination, and/or biologic products through statistical trending and signal detection.
- Providing tools and reports to monitor Key Performance Indicators (KPIs) applicable to postmarketing issues impacting the organization. Establish and maintain the Allergan medical device, pharmaceutical, combination and biologic products Signal Detection Program, including the tracking of action items and monitoring of associated performance metrics.
- Coordinating appropriate cross functional response to product signals and program action items to ensure compliance and continuous improvement.
- Participating in development projects, as a software developer or supported validation/verification activities.
Additionally, the Quality Engineering Specialist will work with the Device Safety Analytics (DSA) data warehouse owner to facilitate updates and maintenance releases, as necessary, to improve data quality and accuracy, and to foster compliance.
KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE:
% of Time or Importance
Manage projects in post marketing quality as required, to improve post market monitoring and/or complaint processing. Lead global cross-functional teams on assigned projects to ensure business objectives are met, including compliance. Lead and support continuous improvement activity associated with Quality Engineering & Analytics objectives.
Develop applications and support verification/validation activities using PLSQL, Business Objects, Microsoft Power BI, etc.
Oversee Signal Detection / Signal Analysis quarterly meetings and the
associated process in the areas of medical device, pharmaceutical, combination, and biologic products. Establish and maintain both the signal detection technical process and the business process. Working collaboratively and cross functionally, establish systems requirements for trending, signal detection, and signal analysis of post market data. Design and develop analytic reports. Responsibilities include: meeting facilitation, developing slides/reports in a format that is easily understood by the audience, and presenting data/material at established frequencies. Manage the action item process to ensure timely closure, including monitoring of the action item process with appropriate performance metrics.
Design and develop reports using Business Objects, Excel and other analytic tools (such as Microsoft Power BI) as assigned in support of Quality Engineering objectives.
Establish and maintain post market performance measures for management
and/or quality review meetings. This includes providing metrics, KPI, data, and presentation materials for management/quality reviews and other business needs. Develop program that is self-sustaining and accurate, with efficient workflows. This includes designing and developing analytic reports to improve efficiencies.
Facilitate data warehouse system updates, maintenance releases, and act as backup to database owner.
JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):
The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Education and Experience
- Bachelor’s degree in Biomedical Engineering, Pharmaceutical Sciences, Computer Science, Engineering, related discipline, or equivalent work experience is required.
- 5-7 years of experience in Medical Device, Pharmaceutical, and/or Biologics.
- 3-5 years of experience in quality analytics, quality assurance, or quality engineering related responsibility.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- Expertise in post market monitoring for Medical Device, Pharmaceuticals, Biologics and/or Combination Products.
- Knowledge of Medical Device, Pharmaceutical, and Biologics complaint processing practice and requirements.
- Demonstrated knowledge of quality system requirements for Medical Device, Pharmaceuticals,
- Biologics and/or Combination Products (including but not limited to 21 CFR parts 4, 210, 211, 601, 820; ICH Q10, etc. and equivalent ISO standards).
- Strong analytics skills in business intelligence platforms, including Business Objects.
- Skilled at creating meaningful and actionable metrics and Key Performance Indicators (KPI).
- Advanced ability with spreadsheets, utilizing features such as advanced functions, nested functions, conditionals, look-ups, and pivot tools.
- Demonstrated aptitude to learn new analytic techniques, including business intelligence platforms, statistical methods, and analytic tools.
- Strong leadership skills commensurate with project management requirements for global teams.
- Ability to work collaboratively with clients and peers to generate project requirements and solve
- business problems.
- Excellent proficiency with MS Office applications, and the ability to quickly learn software applications to support report development, presentations and written reports, etc.
- Excellent oral and written communication, including presentation skills, with the ability to interface effectively and professionally at all levels.
- Ability to work on cross functional teams and apply influencing skills, along with the ability to partner with key internal and external stakeholders.
- Knowledge of computer programming languages and data visualization highly preferred.
- Quality Engineering training and/or certification preferred.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 5 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.