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 114,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of
- 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
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists
The Opportunity
The Senior Director, Technical Quality establishes, maintains and improves quality system programs, policies, procedures, compliance and best practices across the Division. Specifically, this position provides Abbott Diabetes Care (ADC) Division Quality leadership for Design Control, Design Transfer to Manufacturing, on market risk assessments and product portfolio risk management. The position ensures support of new product development programs, change to on market products, assessment of risk for all on market products, ensuring design changes are transferred into manufacturing appropriately, including transfer into complaint investigations. The scope of this role applies to all ADC sites. This role directs the following functional areas; Digital (App, Cloud & API), Hardware (readers, meter, connected pens, connected partners products), Non-Product Software and Risk Management. Must work with multiple ADC functions (RA, Ops, R&D, IT all levels up to and including division president).
This leader is responsible for translating the vision for quality assurance into tangible organizational goals that will assure that ADC has policies, processes and procedures in place to ensure that design control, Test method/Analytical validation and software development (product and non-product) activities of ADC, meet applicable quality and regulatory standards, divisional and local requirements. She or he ensures the design and development of new and existing products through the management of an effective Design Control system at the divisional, site and program level. They help ensure the consistency of product through strong document and labelling control, training, software, test method and design validation systems. This individual must utilize problem solving skills with limited guidance/oversight to fit the business and quality needs. Circumstances may require the incumbent to be creative and motivating, especially when working with teams and influencing others who are not a direct report.
What You’ll Work On
- Establish, implement, maintain and monitor policies and procedures for Product Lifecycle Management in accordance with corporate, division and applicable regulatory requirements with respect to ADC sites and suppliers, including Design Control, Validation, Product Storage, Handling, and Distribution and Post Market Data evaluation.
- Assure line of communication with DVP QA & C and Senior Leaders on critical quality issues that may result in potential business interruption.
- Develop quality strategy to achieve business objectives at the division level while ensuring systems are in compliance with global regulatory requirements, making key decisions on product quality and regulatory conformance issues.
- Ensure Quality Records required for DHF, DMR, Document Control and Training are appropriately implemented as it relates to all areas for Technical Quality & Design Controls.
- Interface with other functional groups to plan and implement monitoring, measurement, analysis and improvement processes needed to demonstrate conformity to product requirements.
- Oversight of design control requirements of externally developed products and services.
- Identify organizational development needs and establish plans to assure that skills of group keep pace with business growth and change.
- Authorize cost efficiency projects that contributes to Division margin improvement initiatives.
- Decision and recommendations made by this position have a direct impact on marketed items for domestic and international sales.
- Assure business continuity in leadership positions and critical roles through talent management planning and development.
- Interface with outside regulators (FDA, Ministries of Health, Notified Bodies, etc.) and other government regulatory bodies, as required.
Qualifications
- Bachelor's Degree in a scientific or technical field required.
- Master's Degree in a business or a technical field desired.
- Minimum 15 years of experience in the Quality or Compliance and Technical discipline, in the Medical Device Industry or other FDA regulated industry.
- Demonstrated progression of leadership responsibility required.
- Articulate and able to communicate effectively with Corporate Officers, DVPs, directors, managers and employees across the corporation.
- Ability to influence decisions made by Operations, R&D, Commercial, and other disciplines to maintain customer satisfaction and division expectations.
Key Success Factors
- Technical Expertise – understanding various standards for medical devices globally (e.g. IEC 62304 Software Lifecycle processes, IEC 60601 Series - Medical Electrical Equipment, ASTM Standards).
- Stakeholder Engagement & Cross Functional Collaboration – effective communication with both internal & external stakeholders, including regulatory agencies / bodies; able to ensure alignment & compliance.
- Innovation & Adaptability – staying ahead with the latest technology & being able to integrate them into our quality processes. Being flexible, adaptable & responsive to changes in regulations, business demands & product development.
- Regulatory & Compliance Knowledge – deep understanding of global regulatory requirements & being able to navigate the regulations.
- Risk Management – knowing what a robust risk management process looks like; being able to identify, assess, and mitigate risks throughout product lifecycle (ISO 14971).
APPLY NOW:
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal
The base pay for this position is
$211,600.00 – $423,200.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 20 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf