Abbott · 6 hours ago
Director, Quality Assurance - Abbott Vascular
United States - California - Santa Clara
Full-time
Onsite
Director/Executive
$149K/yr - $299K/yr
12+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The role involves ensuring robust Design Control activities for product quality and reliability, monitoring compliance with regulations, and developing organizational talent.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
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
Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI regulations, etc.)
Recommends and implements changes to the Quality System as the result of changing regulations, continuous improvement and/or business needs
Ensures rigorous and diligent Design Control practices, including data-driven stage-gate reviews, robust characterization and validation, and stakeholder-focused success criteria for all stages, including manufacturing transfer and commercial readiness
Ensures that appropriate specifications are assigned for materials, process parameters, in-process and finished good testing, etc, and that these specifications are justified with appropriate characterization and validation data
Demonstrates strong product knowledge, problem solving, change management, results orientation, and data-driven decision making
Builds strategic partnerships with internal stakeholders, including operations, regulatory affairs, R&D, clinical, operations QA, and ensures alignment of goals and critical success factors for product development, approval, and manufacturing needs
Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers
Qualification
Required
Bachelor's degree required in a related field or an equivalent combination of education and work experience
Minimum 12 years of relevant career experience required
Creates mid- to long-range QA R&D 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; consequences of erroneous decisions or recommendations would normally result in failure to achieve goals critical to the major objectives of the organization and would seriously affect the financial, employment, or public relations position of the company
Monitors 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
Preferred
Master's degree preferred
Benefits
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
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