Director QA Sign In English United States > Milpitas : 510 Cottonwood Drive More (-9) Apply Apply with LinkedIn View Application More (-9) Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 73,000 people. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.       JOB DESCRIPTION: Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.   Primary Job Function: The Director of Quality Assurance is responsible for the development and execution of the strategy and plan for the division quality function. This position is also responsible for providing direction to the functional area to ensure high-quality, safe and effective products and/or services that are compliant with regulatory expectations. Incumbents in this position will direct the quality efforts of the applicable functional area in support of compliance and business objectives and will ensure that adequate talent and other resources are available to meet the challenges of the organization. This job description encompasses the various disciplines/functions with the quality organization, and will be used by Quality Directors that oversee the following areas: • Manufacturing Site Quality Management (IQA, Quality Engineering, Design Control, Document Control, V&V, etc.) • Quality Systems Management (Implementations, Integrations, Compliance, Training) • Complaints (Risk Management, Adverse Event Reporting, Post Market Surveillance, Metrics) Core Job Responsibilities: Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Leadership • Lead the functional area as a quality and compliance decision maker to ensure the safety and effectiveness of the products and/or services • Represent the face of Abbott quality and compliance to external stakeholders, including regulatory agencies and customers • Consistently act as a role model for the Abbott values and maintain high expectations of the organization and its people to achieve Abbott’s quality vision • Drive customer-focused quality and strategy based on risk management principles, sound science, legal and regulatory requirements • Set goals for the applicable functional area to advance the business and scale the infrastructure to support business needs • Maintain positive relationships internally and externally Strategic Planning & Execution • Translate the vision and business strategies of the Quality division into executable action plans • Execute business strategy in the function while balancing cultural, financial and resource constraints • Interpret applicable regulations and apply appropriate standards to the quality planning process • Foster a culture of continuous improvement in the functional organization • Act as a conduit of market intelligence to predict changes in the business environment and align the quality strategy accordingly • Ensure the quality strategy is transparent and the organization is engaged in its execution • Allocate resources based on quality system priorities and corresponding business needs Quality Systems • Implement a value-added quality system based on sound science and application of the appropriate quality, regulatory and legal requirements that meet diverse market needs • Monitor the performance of products and/or services and the quality system using appropriate metrics, and demonstrate a commitment to continuous improvement • Embed quality tools and risk management processes within the quality system • Stay abreast of changing requirements and proactively implement changes to the quality system Problem Solving • Use quality and risk management tools to make timely, science-based decisions that protect our customers and brand • Implement appropriate solutions that address complex technical, legal and global regulatory standards • Demonstrate confidence during difficult decision-making and influence business partners to ensure acceptable quality outcomes • Champion problem-solving techniques to provide options for solving business issues impacting services and/or products both on the market and in development • Use business excellence tools and processes to foster continuous improvement Human Resources • Attract, retain and proactively develop a pipeline of key talent through coaching, training, experience development and internal/external recruitment • Identify business-critical positions and establish robust succession planning strategies • Anticipate key vacancies and develop contingency plans to avoid disruptions in managing the quality system • Establish high standards for performance management and accountability to achieve business objectives Financial Results • Establish quality as a differentiator that drives profitability and customer satisfaction • Manage a cost-effective quality system with a focus on product cost and gross margin improvements while maintaining quality and regulatory compliance • Maintain financial stewardship with consideration of economies of scale and impact of change to cost profile(s) Supervisory / Management Responsibilities: Director Quality Assurance report to the Divisional Vice President of Quality Assurance. Each Director position will have various organizational sizes, ranging from 5 – 50 direct and indirect reports. Each Director will have Sr. Managers and Managers on their direct staff. Position Accountability / Scope Indicate the reporting relationships, products, budgets, throughput, level and purpose of contacts (internal and external), or other scope measures that are key to this position. • Decisions and recommendations made by this position have a direct impact on marketed items for domestic and international sites. • This position is the chief interface with the FDA and other regulatory bodies. • This position is responsible for final product releases from the division. • Failure to manage the responsibilities of this position could result in shutdowns of production lines which results in reduced revenues and company profits. • Failure to maintain quality system compliance can lead to warning letters or more sever regulatory actions resulting in multi-year impact.   Minimum Education: Bachelor’s Degree in Engineering, Chemistry, Biology, or related science/technical field or an equivalent combination of education and work experience. Advanced degree preferred. Minimum Experience / Training Required: • Exposure across different cultures, groups, divisions, functions, locations, and management styles • Experience operating with a broad business perspective; experience actively identifying experience and knowledge from other parts of Abbott to solve quality issues • Experience with businesses in different phases of the business lifecycle, and the quality issues associated with these phases • Increased autonomy and responsibility for a functional area (e.g. decision making, delegation, developing departmental structure, resource needs, and strategic plans) • Quality systems/operations and/or laboratories experience • Quality manager/supervisor experience • Quality planning (new product introduction, product assurance, R&D quality) experience • Professional certification supplemental to job experience • Supplier performance (vendor, OEM or TPM) experience • Regulatory compliance (recalls/field actions, inspections, submissions) experience • Site and divisional-level experience • Demonstrated understanding of US and international regulatory and compliance requirements • Interactions with external regulatory/quality contracts and/or trade organizations and fostering relationships with government/regulatory agencies • Experience with quality management tools (Six Sigma, CAPA) • Experience with product life cycle management; quality by design, and customer-focused quality An individual with these experiences and training generally would have a minimum of 15 years’ experience with at least 5 years in a supervisory role in a regulated industry (Biotech, Pharma, Medical Device manufacturing).         JOB FAMILY: Quality Assurance       DIVISION: AMO Medical Optics          LOCATION: United States > Milpitas : 510 Cottonwood Drive       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: Yes, 15 % of the Time       MEDICAL SURVEILLANCE: Yes       SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)       Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.       EEO is the Law link - English:       EEO is the Law link - Espanol: Apply Apply with LinkedIn View Application More (-9) Posted 11 Days Ago Full time 30017462 About Us Abbott   is about the power of health. For more than 125 years,   Abbott  has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of  Abbott   come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at  Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer,  Abbott  welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter Similar Jobs Follow Us

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