Sr. Quality SystemsCAPA Engineer
Job Location:
Pleasanton, CA - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
JOB DESCRIPTION:
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.
Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
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 Senior Quality Systems Engineer assures products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success. The position employs an individual skilled in advance quality assurance techniques with an in-depth understanding of the ISO 13485 Quality Standard and US 21 CFR 820 QSR. Areas of focus will include improving quality system infrastructure performance metrics and ISO FDA and GMP compliance.
What Youll Work On
- Assure compliance with corporate and divisional requirements regarding metrics reporting for the Management Controls / Management Review and CAPA quality systems.
- Assure the collection compiling reporting and dissemination of key quality and compliance metrics/data are completed within the requiring timing.
- Complete trend analysis of data as appropriate to ensure proper actions can be determined or assessed.
- Perform and assure timely follow-up activities in support of key quality and compliance metric/data goals and policy/procedural requirements
- Develop and provide data and analysis in support of Management Controls / Management Review and CAPA Quality Systems
- Identify and implement opportunities for continuous improvement
- Identify opportunities to apply continuously improve and redefine quality systems and controls product-related processes in accordance with applicable internal domestic and international quality regulations US 21 CFR 820 (QSR) ISO 13485 etc.
- Represent Quality Systems as required in support of cross-functional projects
- Assist in company preparations for hosting external audits
- Participate in external and internal audits
- Assists management teams to ensure timely closure of audit observations. Lead non-conformance investigation teams to identify root causes and effective CAPAs
- Lead coach and mentor non-exempt and entry level exempt personnel on quality principles and procedures
- Function as part of risk assessment teams to identify product quality system and compliance requirements.
- Function as part of special project teams to identify compliance gaps and develop and execute strategies to close gaps.
Required Qualifications :
- Bachelors degree in engineering or Technical Field
- Minimum 5or more years of Engineering experience and demonstrated use of Quality tools/methodologies
- knowledge of FDA820 GMP ISO 13485 and ISO 14971
Preferred Qualifications:
- Project management and leadership skills including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues
- Internal and External Audit experience
- MS or higher degree in a technical discipline
- Advanced computer skills including statistical/data analysis and report writing skills
- medical device industry experience
- ASQ CQE or CQA certification
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.
The base pay for this position is
$90000.00 $180000.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
HF Heart Failure
LOCATION:
United States > Pleasanton : 6101 Stoneridge Dr
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) 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: EEO is the Law link - Espanol: Experience:
Senior IC
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
