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:
Job Title
Quality Assurance Manager
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 of which you dream.
- 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
We are seeking a Quality Assurance Manager for Abbott Vascular in our Temecula, CA site. This is an onsite role.
Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.
Job Summary
This position provides leadership and guidance for the department, has responsibility for recruiting, developing and retaining talented employees, supports company goals and objectives, and communicates key information to staff members and senior management.
What You’ll Work On:
- Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
- Monitors daily work operations and provides direction and guidance to lower-level supervisors, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
- Monitors compliance with company policies and procedures (e.g. compliance with FDA, MedDev, DOH regulations etc).
- Notifies appropriate personnel for possible litigation and aids and responds to requests for information related to litigation concerns.
- Monitors complete complaint handling process from first contact through closure of file and notifies appropriate personnel of issues that prevent a smooth flow.
- Maintains personnel records and where appropriate develops work schedules for departments customer complaint hotline to ensure no customers are transferred to v-mail during business hours.
- Develop strategies for regulatory reporting of medical devices.
- Coordinate MDR, Vig, MHLW, reporting activities for a variety of device regulatory requirements including: US post market studies, IDE exemptions, international regulatory reporting and annual summaries.
- Develop and deliver presentations to global regulatory agencies and other business units.
- Topics may include MDR position strategies, compliance issues or new initiatives such as Global Harmonization.
- Coordinate Division comments on proposed regulations.
- Represent Division in industry feedback for changes in regulatory law.
- Serve as internal consultant on regulatory issues such as regulatory processes, interpretation of regulatory laws or review of proposed regulatory position changes.
- Participate in department systems development initiatives, which may include complaint database development.
Required Qualifications
- Minimum of a Bachelor's degree An equivalent combination of education and work experience
Experience
- Minimum of 6 years of experience within the healthcare, medical device, or biotechnology industry.
- Medical Device experience highly preferred
- Monitors progress of exempt individuals, teams, supervisors or nonexempt technical individuals toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility.
- 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 and the improved utilization of human and material resources within the assigned area or related departments; facilitates others involvement in the continuous improvement program; investigates and solves problems that impact work processes and personnel within the assigned unit.
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
$99,300.00 – $198,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
AVD Vascular
LOCATION:
United States > Temecula : Building E - TE
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing 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: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
