Sr. Quality Systems/CAPA Engineer

Abbott; Pleasanton (CA); On-site; USD 90,000 - 180,000; Full time

Job summary

Abbott in Pleasanton, CA seeks a Senior Quality Systems Engineer to ensure products meet quality standards and comply with ISO 13485 and US 21 CFR 820. You will lead cross-functional teams, drive CAPA, and support external audits.

The role emphasizes data-driven metrics, continuous improvement, and strong collaboration with engineering, manufacturing, and regulatory groups. Relevant QA experience in medical devices is preferred.

Qualifications

• Minimum 5 or more years of Engineering experience and demonstrated use of Quality tools/methodologies.
• Knowledge of FDA 820, GMP, ISO 13485, and ISO 14971.

Responsibilities

• 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.

Skills

Quality tools/methodologies

Engineering experience

Audit experience

Education

Bachelor’s degree in engineering or Technical Field

Tools

FDA 21 CFR 820

ISO 13485

ISO 14971

Statistical analysis

Job description

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 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. You’ll 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 bachelor’s 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 You’ll 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 :

• Bachelor’s 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

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.

The base pay for this position is

$90,000.00 – $180,000.00

In 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: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf