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 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
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.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- 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
This position works out of our Alameda, CA location in the Diabetes Care division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
As the Senior Specialist Quality you will be responsible for implementing and maintaining an effective Quality System.
What You’ll Work On
Responsible for implementing and maintaining the effectiveness of the Quality System.
Independently contributes to Quality System processes which may include training, corrective action and preventive action (CAPA) activities, product and process planning, and quality audits.
Determines quality attributes and requirements. May provide technical assistance.
Project manages quality escalations and works cross-functionally with appropriate SMEs.
Responsible for managing and tracking responses to regulatory agencies.
Independently completes documentation in a timely manner and in accordance with business standards.
Performs other related duties and responsibilities, on occasion, as assigned.
Understands and complies with applicable EHS policies, procedures, and guidelines.
Works under general supervision of more experienced staff who review results for overall accuracy, completeness and sound judgment; identifies and quantifies technical risks and their consequences relative to the success of part of a project; recommends appropriate action; decisions or recommendations would typically achieve department / project objectives; drives functional performance to ensure that cross-functional standards and expectations are met; may assist in the training of personnel as directed by management; may mentor others.
Required Qualifications
Bachelor's degree (preferably in science, engineering or a closely related discipline) or equivalent experience and demonstrated competence
Additional post-graduate education may contribute toward the desired years of experience
5+ years of relevant experience (such as Quality, Compliance, Engineering) within a regulated environment (such as medical device, diagnostics or pharmaceutical industries) to develop the
competence required to meet the skills and responsibilities of the position.
Preferred Qualifications
Candidates / incumbents should possess the following:
- knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for
medical devices;
- Previous experience with regulatory body;
- Knowledge of software regulations and compliance (21 CFR Part 11);
- Knowledge of ISO 13485;
- Knowledge of quality management techniques and the application and principles of quality engineering;
strong knowledge and
application of concepts, practices and procedures;
- Ability or aptitude to work on problems that are complex in scope where analysis of situations or data
involves multiple competing factors;
- Understanding of statistics;
- Ability to form and develop interpersonal, professional relationships; display socially and professionally
appropriate behavior;
- Ability to work independently and in groups; ability to work cross-functionally;
- Demonstrated initiative and problem-solving skills; critical-thinking skills;
- Ability and aptitude to use various types of databases and other computer software;
- Ability to prioritize;
- Strong organizational and project management skills;
- Ability or aptitude to lead without direct authority;
Apply Now
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
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
$82,100.00 – $164,100.00
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, 10 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), 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