-

Senior CAPA Quality Engineer

Location United States - California - Alameda Category Quality
Apply Now
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 114,000 colleagues serve people in more than 160 countries.

Senior CAPA Quality Engineer

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 for free medical coverage in our Health Investment Plan (HIP) PPO medical 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

Personalized healthcare is the future. Bio-wearable technology will digitize, decentralize, and democratize healthcare, enabling consumers to take control of their own health. Diabetes is a growing problem worldwide, and at Abbott Diabetes Care (ADC) we are helping people with diabetes lead healthier, happier lives.

Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, and we‘re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels. ADC is responsible for the development and launch of new digital products based on the FreeStyle Libre platform, the world’s #1 continuous glucose monitoring (CGM) solution.

This position will be based out of Abbott Diabetes Care Division in Alameda, CA and the individual will be expected to be onsite Mon-Fri.  The position will be responsible for driving CAPA projects through its entire life cycle, mentor lower-level engineers, while strategizing continuous process improvements that aid in improving the CAPA program.

What You’ll Work On

  • Lead, mentor and motivate a team of Quality Engineers.
  • Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.
  • Accountable for leadership and oversight of the CAPA system, and associated deliverables.
  • Provide guidance, insight and training to the team and the wider business around CAPA process, quality standards, and regulatory requirements.
  • Lead and/or contribute to continuous improvement initiatives and projects.
  • Provide subject matter expertise during audits and inspections.
  • Represent CAPA QA in cross functional meetings (site and division).•
  • High proficiency leading meetings and communications for QA system information, concerns, and updates.
  • Lead, develop, and mentor others with QA data analysis, trending, and reporting.  High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.
  • Adept at staying current with organizational and industry information and routinely mentors/leads other members of the organization on quality assurance practices.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Required Qualifications

  • B.S. in Engineering, Technical Field, Life Science or closely related discipline. Equivalent combination of education and work experience will be accepted
  • Masters degree preferred
  • Minimum 6 years in Quality or related field experience.
  • Previous CAPA and/or Quality Assurance/engineering experience and demonstrated use of quality tools/methodologies.

Preferred Qualifications

  • Prior medical device experience preferred.
  • Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
  • Solid communication and interpersonal skills.
  • Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
  • Advanced computer skills, including statistical/data analysis and report writing skills.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel approximately 20%, including internationally.

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.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Diabetes

We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.



The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.

Close the popup

No locations found

Apply Now

Get notified for similar jobs

You'll receive updates once a week

Email should not be empty Please enter valid email
Success! Successfully subscribed for similar jobs Failure! You have already subscribed for this job Failure! Failed to subscribed for similar jobs

Get tailored job recommendations based on your interests.

Job seekers Also Viewed

  • Staff CAPA Engineer

    Location United States - California - Alameda Category Quality

    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

  • Senior Specialist Quality Assurance

    Location United States - California - Alameda Category Quality

    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

  • Senior Development Quality Engineer

    Location United States - California - Menlo Park Category Quality

    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

  • Staff Engineer, Software Design Quality

    Category Quality

    We are looking for a skilled professional with 8+ years in software development and design quality engineering. Responsibilities include overseeing medical software development, conducting risk assessments, and ensuring compliance with FDA regulations. Expertise in software verification, validation, and quality methodologies is essential for success in this role.

  • Software Complaint Investigation Engineer

    Location United States - California - Alameda Category Quality

    Are you looking for a role where you can investigate software application issues in medical devices? Bring your 3+ years of software testing experience, collaborate with cross-functional teams, and enhance product quality through effective complaint management and continuous improvement initiatives. Join us to make a meaningful impact in healthcare.

No recommendations found

Similar Jobs

No recommendations found

Job Id 31116123 Location United States - California - Alameda Medical surveillance No Division ADC Diabetes Care Travel Not specified Additional Location 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)

CREATING POSSIBILITIES

sales-static-events
INNOVATIVE BENEFITS
We support our colleagues around the world as they care for themselves and their families with offerings tailored to their unique needs.
sales-working-phenom
DIVERSITY & INCLUSION
We strive to provide environments where all employees feel welcome and able to bring their full selves to work. To do this we integrate diversity, equity, and inclusion across Abbott.
sales-working-phenom
SUSTAINABILITY FOR OUR FUTURE
At Abbott, sustainability means managing our efforts so we can help the greatest number of people around the world live fuller lives through better health.

WE'RE RECOGNIZED AROUND THE WORLD

img1
DOW JONES SUSTAINABILITY INDEX
img1
BEST CORPORATE CITIZENS
img1
FORTUNE CHANGE
THE WORLD
img1
FORTUNE'S MOST ADMIRED COMPANIES
img1

JOIN OUR TALENT COMMUNITY
We will notify you about relevant positions, and keep you in mind when we have interesting opportunities.
JOIN NOW
AN EQUAL OPPORTUNITY EMPLOYER

Abbott welcomes and encourages diversity in our workforce including Minorities, Women, Individuals with Disabilities and Protected Veterans.

> EEO (ENGLISH)               > EEO (SPANISH)                > PAY TRANSPARENCY NONDISCRIMINATION PROVISION

We provide reasonable accommodation to qualified individuals with disabilities. U.S. residents only: To request accommodation, please call 224-667-4913 or email corpjat@abbott.com.