Director Design Quality - Molecular Diagnostics Div (31029553)
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 113,000 colleagues serve people in more than 160 countries.
Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.
Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people
Molecular Diagnostics at Abbott at it’s Des Plaines, IL Headquarters has an opportunity for the Director Design Transfer within QA, with 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 Molecular Diagnostics Div.
What You’ll Work On:
•Responsible for implementing and maintaining the effectiveness of the quality system.
•Division responsibility and tracking metrics of the design control process through development of policies and procedures.
•Member of the Molecular Diagnostics Div. Product Development Management Review Board (PDMRB). Manage and track Design Control Oversight Review Board for Product Review and Metrics to adhere to Molecular Diagnostics Div. Design Control policies and practices to ensure a consistent level of quality and compliance throughout the preproduction 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.
EDUCATION AND EXPERIENCE, YOU’LL BRING:
- Bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant In regulated environment to develop competence to meet the skills and responsibilities of the position
- 10 plus years work experience in Quality or related field experience.
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,
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
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.
- Advanced education (PhD in life science) is preferred.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.