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Veterans at Abbott

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Abbott Manager Product Surveillance in Sylmar, California

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

MAIN PURPOSE OF ROLE

Manage team of data analysts responsible for creating, revising and implementing product and process performance metrics, KPIs for the divisional and/or corporate leadership. Oversee customer response letters, RFIs, CER and other post market surveillance inputs. Provide project management and systems/automation oversight to PPG process improvements.

MAIN RESPONSIBILITIES

•Responsible for communicating KPI’s and product performance to local and divisional senior management. Prepare and present complaint information for Management Review.

•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 and PPG process performance 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. similar incidents for MIRs, customer response letters, RFIs, CER inputs, PMS inputs), maintaining regulatory compliance and optimizing productivity.

•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, EUMDR).

•Oversee the investigation into all trends highlighted as part of the monthly process, and highlight any significant unresolved issues to senior management as required.

•Provide project management center of excellence to PPG/PPE through coaching, tools, techniques and project management training resources. Establish process to review PPG owned CAPAs, projects

  • Utilize process and product metrics to define staffing model for PPG/PPE

  • Liaison with Global and Divisional teams on system projects and ensure system support availability to PPG/PPE

  • Improve efficiencies by automation of PPG processes

QUALIFICATIONS

Education

Bachelors Degree (± 16 years)

Math, Science, or Engineering disciplines preferred) or equivalent in a technical or analytical discipline

Or

an equivalent combination of education and work experience

Experience/Background

Minimum 5 years

overall quality experience in a FDA/ISO regulated environment

Some

Demonstrated experience in leading teams, organizing and managing projects and developing/coaching/guiding team members (either direct and indirect reports)

Some

Experience of product performance monitoring activities in a relevant industry/discipline

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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