Abbott Quality Assurance Manager, Data Analysis in Alameda, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Abbott Diabetes Care is looking for a QA Manager of Data Analysis to manage our team of data analysts and be responsible for creating, revising and implementing metrics and KPIs for the divisional and/or corporate leadership. This person will report into our Manager of Product Quality Engineering (PQE).
• Responsible for communicating KPI’s and product performance to local and divisional senior management.
• Responsible for ensuring that the group generates and reports metrics (e.g. complaints and product performance) to help to identify potential issues and areas for improvement (e.g. Design or Operations functions).
• To ensure the team monitors product performance in the field and translates the performance information into metrics to support product improvements for the division's manufactured and distributed product.
• To manage and develop a team of employees within the managers area of responsibility and be accountable for their performance whilst providing direction to ensure metrics (e.g. complaint metrics) are generated and necessary work performed in a timely manner (e.g. complaint investigations), maintaining regulatory compliance and optimizing productivity.
• To manage the Analysis Team in accordance with established divisional and Abbott procedures, ensuring compliance to FDA, ISO and worldwide regulations.
• To manage the effective tracking and trending of necessary metrics (e.g. complaints and follow up investigations) in a timely manner in accordance with divisional requirements ensuring compliance to applicable regulations.
• Seek ways to drive through improvements in terms of productivity, quality and cost control in line with Business Excellence initiatives.
• To ensure the Data Analysis team monitors product performance in the field and translates the performance information into metrics to support product improvements for divisional manufactured and distributed product.
• Generate local and world wide monthly trend reports, produce trend related queries and ensure trend procedures are in accordance to divisional and corporate requirements and meet appropriate regulatory guidelines and regulations (e.g. FDA, ISO 13485, & Medical Device/IVD).
• Oversee the investigation into all trends highlighted as part of the monthly process, and highlight any significant unresolved issues to senior management as required.
• Prepare and present complaint information for Management Review.
B.S. degree in a technical or analytical discipline
5+ years experience in an FDA/ISO regulated environment
Preferred: Demonstrated experience in leading teams, organizing and managing projects and developing/coaching/guiding team members (either direct and indirect reports)
Experience of product performance monitoring activities in a relevant industry/discipline
Data Analysis experience preferred
Strong presentation skills
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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