Abbott

Sr. Quality Systems/CAPA Engineer

Abbott$90K — $180K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in engineering or a technical field
  • 5+ years of engineering experience with quality tools/methodologies
  • Knowledge of FDA 21 CFR 820, GMP, ISO 13485, and ISO 14971

Responsibilities

  • Ensure compliance with metrics reporting for Management Controls and CAPA quality systems
  • Collect, compile, and disseminate key quality and compliance metrics
  • Conduct trend analysis to determine necessary actions
  • Perform timely follow-up activities to meet quality goals
  • Develop data and analysis for Management Controls and CAPA Quality Systems
  • Identify and implement continuous improvement opportunities
  • Represent Quality Systems in cross-functional projects

Benefits

  • Health and wellness benefits for you and your family
  • Opportunities for diverse career development
  • Supportive work environment fostering collaboration
  • Access to resources for continuous learning and growth
Full Job Description
JOB DESCRIPTION:

Job Description

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 5 or 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


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.

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)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

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Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ

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