Specialist Quality Assurance
Specialist Quality Assurance
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$ 79500 - 138700
1 Vacancy
Job Description
JOB DESCRIPTION:
Specialist Quality Assurance
Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution
A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity working mothers female executives and scientists.
The Opportunity
The primary function of the Quality Specialist is to assist in maintaining the quality system.
The role can have responsibility for one or more of the following processes:
Batch release
Complaint Coordination
Metric maintenance
Surveillance Program
Testing Program
Document Control
Exception Report and CAPA System
Batch and Sample Retention and Maintenance
This position will be based out of our Abbott Diabetes Care in Alameda CA and the individual will be expected to be onsite Monday-Friday.
What Youll Work On
Assist with administration and ensuring compliance to Quality Management Systems including:
Complaints Coordination Batch Release Exception Reports CAPA Document Control Surveillance Testing Batch and Sample Retention and Maintenance Metric etc.
Actively monitors Third Party Manufacturers data and Support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory (cGMP ISO) regulations.
Reviews GMP related documentation for compliance such as batch records and associated data related to product manufacturing testing and release validation protocols and reports labels product specifications and other documentation as required.
Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations in the Manufacturing area as required.
Maintains product complaint logs to identify and report recurring issues to quality assurance management and product development. Collaborate with other internal groups to respond to product inquiries and issues.
Writes and revises SOPs controlled forms and related documents to ensure best practices and alignment with current operations.
Collaborates with members of the Quality Assurance team working on special projects.
Participate on permanent and temporary teams which are process or project driven.
Become familiar and subject matter expert on electronic support systems TraqWise GQMS TeamCenter compliance wire etc.
Collect analysis and publish quality metrics.
Provide data for support of budgetary submissions.
Assist with other support duties as assigned.
Required Qualifications
Bachelors Degree with a minimum of 2 yrs of experience or equivalent education and work experience will be accepted.
Prior experience in the medical device industry and/ or quality systems are required.
Preferred Qualifications
Strong working knowledge of FDA Code of Federal Regulations as it applies to medical device manufacturing including cGMP ISO14971 as well as complaint handling systems a huge plus.
Related work experience in customer complaints and product nonconformances strongly preferred.
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
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 on Facebook at and on Twitter @AbbottNews.
Divisional Information
Medical Devices
General Medical Devices:
Our medical devices help more than 10000 people have healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than 500000 people with diabetes from routine ngersticks.
Diabetes
Were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were revolutionizing the way people monitor their glucose levels with our new sensing technology.
The base pay for this position is
$79500.00 $138700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 2801 Harbor Bay Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
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) 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: EEO is the Law link - Espanol: Experience:
Unclear Seniority
Employment Type
Full-Time
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