Abbott Director Design Quality, Transfusion Diagnostics in Abbott Park, Illinois

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Division responsibility for the quality assurance of product development. As a member of the Product Development Management Review Board (PDMRB) oversees product design and design changes. Directs Division Design Quality function (responsible for product development and product changes). Review and implement the quality policies, processes, and procedures related to the Design Control subsystem of the Division Quality System. Review and implement appropriate improvements to support an effective Design Control System that links to the appropriate areas of the Quality System. Responsible for tracking the effectiveness of the product development process and establishing quality improvement goals through internal and external quality metrics. Assures the long-term effectiveness of the R&D QA organization and ensure that the needs with respect to product development of the division are met. Manage division-wide quality assurance and quality improvement, including support for product development, design transfer, operations manufacturing, process validation, process control and enhancements, quality metric reporting, supplier qualification, design assurance programs, complaint handling and CAPA programs. Cooperates with external partners to ensure TPM developed products meet the requirements of ADD.

Main Responsibilities

Division responsibility and tracking metrics of the design control process through development of policies and procedures.

Member of the ADD Product Development Management Review Board (PDMRB).

Manage and track Design Control Oversight Review Board for Product Review and Metrics to adhere to ADD Design Control policies and practices to ensure a consistent level of quality and compliance throughout the pre-production and post-market life of the product.

Provides recommendations for improvements to the Design Control policies and practices and/or training of personnel based on regular management review of the effectiveness of the system.

Chair of the Design Control Oversight Review Board that provides management control of the Design Control Quality System.

Responsible for implementing and maintaining the quality system including quality policy, planning, organizational structure to support the quality system, and management review of the quality system to determine its effectiveness through metric tracking.

Responsible for alignment of the Quality System to current regulations. (GMP/ISO, etc.).

Responsible for developing and maintaining a training and certification program for individuals specializing in Design Quality.

Manage human resources: provide direction to staff, approve broad staffing decisions, develop tactics to implement site/division policy, and develop the organization to ensure effectiveness.

Accountability/Scope

Responsible for ensuring that ADD develops and produces products that meet the highest standards for quality and accomplishes this in compliance with all applicable regulatory requirements.

Failure to complete this mission can result in regulatory action against ADD and Abbott and long term failure to meet our quality standards will result in diminished product sales.

The quality of ADD products is a competitive advantage in the market place and any lessening of our standards can have an adverse long term impact on our business.

Review, consolidate, and monitor budgets.

Determine and approve actions to deal with variances.

Level load financial resources and resolve budget differences within the function to meet the overall needs of the QA organization.

Guide, direct, and serve as role model for the organization.

Coach staff and identify key employees to assure long term success of the function.

Influence and visibility extend into the corporate community and with outside regulatory agencies.

Review development plans of subordinates.

Establish succession plans for key positions.

Ensure that goals are aligned with long term needs of the division.

Set long term HR strategy for the area.

Translate business requirements into HR requirements.

Develop personnel and ensure development planning takes place throughout the organization.

Monitor the availability of and development opportunities for individuals within the function and in other areas of the division.

Align functional goals with long range business needs and strategies.

Ensure area functions effectively as a team and assess performance of area as a team.

Review metrics to ensure alignment with strategy.

Make strategic staffing decisions across multiple areas and develop staffing strategy.

Review and approve reward and recognition programs.

May negotiate with customers or regulatory agencies regarding product issues.

Frequently internal contacts on sensitive issues relating to product issues.

Interact with all levels of division management on issues within area of responsibility. (Product Development / Design Control Regulation). Divisional support and review of Strategic Development Programs for R&D deliverables / timeline and QA resources to launch quality products.

Qualifications

A BS degree in engineering or in life sciences is required. Typically , the incumbent would have an advanced degree or significant experience (7 years or more) in Product Development and/or Quality Development Support (R&D and/or Technical Support of on-market products). Knowledge of regulations and standards affecting IVDs and Biologics (e.g. QS Regulations, EN 46000). Experience in Quality Assurance is an important element for a complete understanding of the job responsibilities. Experience should include budgetary responsibility, managing product development and launch process, supervision of multiple groups and teams. Knowledge of the Design Control Quality subsystem (QSR 820.30) and experience in product development. In depth knowledge of the technology of the ADD product portfolio, the needs and demands of our customers and the markets we serve, and the requirements of the regulatory bodies that govern our Quality System. Operations experience is especially helpful. Quality experience is an important element to meet Design Control Regulations. Product Development and Product Launch experience is helpful. Knowledge of advanced methods for Product Development such as Design For Six Sigma and DMAIC methodology are desired.

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