Abbott

Engineer, Sr. Quality Assurance

Abbott • $78K — $156K *
Plano, TX 75025In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Engineering or Technical Degree or equivalent work experience.
  • 3+ years' experience managing CAPA processes, including root cause investigations.

Responsibilities

  • Analyze and present Quality System data metrics to management.
  • Investigate and resolve quality system corrective and preventive actions.
  • Support and prepare for internal and external audits.
  • Collaborate with cross-functional teams to develop quality improvement plans.
  • Ensure compliance with ISO 13485 and 21CFR 820 regulations through gap analysis and improvement initiatives.
  • Utilize quality tools like Lean and Six Sigma to implement process enhancements.
  • Analyze audit findings and recommend product and process modifications.

Benefits

  • Health and wellness benefits to support you and your family.
  • Opportunities for diverse career growth within the company.
Full Job Description
JOB DESCRIPTION:

Engineer, Sr. Quality Assurance

Neuromodulation

Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

What You'll Work On
  • Analyze Quality System data and present established metrics to senior and executive management.
  • Investigates and resolves quality system corrective actions and preventive actions.
  • Support internal and external audits.
  • Works with cross functional teams to develop sound quality improvement plans that effectively consider the impact of change(s) and the actions required for implementation.
  • Ensures compliance to ISO 13485, 21CFR 820 Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • As appropriate, utilizes Lean, Six Sigma, and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in divisional quality system compliance, device, and process.
  • Analyzes quality audit findings and recommends modifications in products and processes. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
  • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.


Required Qualifications
  • Bachelor's Degree in Engineering or Technical Degree or an equivalent combination of education and work experience.
  • 3+ years' experience in the ownership of CAPA process, to include conducting root cause investigations and developing action plans/effectiveness checks.


Preferred Qualifications
  • Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality system-related issues in a timely and effective manner.
  • Multitasks, prioritizes, and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • 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.
  • Advanced computer skills, including gap analysis and report writing skills.
  • Detailed knowledge of FDA, GMP, and ISO 13485.
  • Six Sigma certification (e.g., ASQ CQE, CQA or Six Sigma certification preferred).


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
$78,000.00 - $156,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
NM Neuromodulation

LOCATION:
United States > Texas > Plano : 6901 Preston Road

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Not specified

MEDICAL SURVEILLANCE:
Not Applicable

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), Continuous walking for prolonged periods (more than 2 hours at a time 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.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

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
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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