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 109,000 colleagues serve people in more than 160 countries.
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.
At Abbott Molecular, we realize the potential of personalized care as the laboratory’s most trusted and preferred source for molecular diagnostic solutions.
We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics.
Our Des Plaines, IL Headquarters has an opportunity for the Director
– Field Quality – within its Quality Team.
The Director will direct and guide the management team in the establishment and achievement of objectives, including all aspects of quality and reliability of products from concept through manufacturing.
Establishes quality systems and plans to assure design and manufacture of the highest quality products to exceed customer requirements.
Interfaces with outside regulatory agencies as an Abbott representative WHAT YOU’LL DO : Recruits, coaches, and develops organizational talent.
Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
Creates an entrepreneurial environment.
Provides general direction to managers, exempt specialists and non-exempt support in various areas, groups and/or operations.
Keeps the organization’s vision and values at the forefront of decision making and action.
Demonstrates effective change leadership.
Builds strategic partnerships to further departmental and organizational objectives.
Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers.
Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers.
Team will be responsible for reviewing medical complaints and potentially reportable events for the purpose of researching and gathering additional information needed to determine MDR and/or Vigilance reportability Filing of all medical events and reportable malfunctions within the required timeframe Document filing decision rationale in the Complaint Handling System Create compliant and practical solutions to cross-functional teams in order to promote accurate documentation of the complaint case, including vigilance processes from a broader scale perspective Coordinates across functional areas, business units, and/or geographies to achieve company or area goals.
Utilizes technical/professional knowledge and skills to establish, interpret and execute company policies in a major segment of the company.
Monitors and ensures compliance with company policies and procedures (e.g., compliance with FDA, regulations, etc.).
Makes and executes operational decisions with a strategic perspective Directs and controls the activities and budget of one or more functional areas, divisions, product groups and/or operations.
Establish Quality Systems that follow regulatory requirements and meet business needs.
Reviews, analyzes, and presents to senior staff and other groups the effectiveness of the Quality System.
Recommends and implements changes to the system as the result of changing regulations and/or business needs.
Analyzes data, makes decisions, or provides recommendations to senior staff regarding quality related crises (e.g., patient injury due to product malfunction).
Communicates quality policies, strategies, and procedures to the organization through written documents, presentations, and discussions.
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.
Less experience may be appropriate with advanced degree.
Knowledge of FDA and ISO Quality System Requirements and other applicable US Code of Federal Regulations for Devices Experience: Monitor’s progress of departments or units toward divisional and company goals; monitors all costs associated with assigned organizational unit; monitors company-wide indicators such as market share and profitability; monitors industry trends and external environment in areas relevant to the assigned organizational unit.
Will perform this job in a quality system environment.
Failure to adequately perform tasks can result in noncompliance with governmental regulations.
Develops and/or identifies new work processes that will have broad applicability throughout the company.
Contributes ideas for improving work processes and achieving organizational goals; investigates and solves problems that impact work processes and personnel in multiple units or departments, develops and communicates a vision for a major segment of the organization.
Creates mid
– to long-range plans to carry out objectives established by top management, develops, and calculates a budget for one or more departments to meet organizational goals: forecasts future departmental or group needs including human and material resources and capital expenditures; determines and establishes organizational structure and supervisory relationships subject to top management approval.
Typically makes decisions that translate programs established by top management into operational plans and schedules; work is performed without appreciable direction.
Preferred Qualifications: Master’s degree, PHD is preferred WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career.
We offer: Training and career development , with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives, and retirement plans Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com