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.
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 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
This position works out of our Plano, TX location in the Neuromodulation Division. 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.
The Quality Systems Engineer will work closely with
development/manufacturing/quality engineering to establish and ensure compliance and quality for product related risk management documentation. Ensure risk management assessments and evaluations for products conform to established standards and agency regulations.
What You’ll Work On
- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Implement quality system processes and CAPA systems designed to meet or exceed internal and external requirements.
- Assist in the planning, development, and execution of streamlined business Quality Systems which effectively identify and resolve quality issues.
- Lead execution of medical device field actions and health hazard evaluations
- Communicates with regulatory agencies worldwide regarding quality system and quality issues.
- Lead, coach, and mentor non-exempt and entry level exempt personnel
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Appropriately document experiment plans and results, including protocol writing and reports
- Lead and implement various product and process improvement methodologies (e.g., Six Sigma, Kaizen and Lean Manufacturing)
- Lead the investigation, resolution and prevention and recurrence of product and process nonconformances
- Support internal and external inspections
- Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
- Performs other related duties and responsibilities, on occasion, as assigned
- Analyze Quality System data and present established metrics to senior and executive management.
Required Qualifications
- Bachelor's degree in engineering or related field or an equivalent combination of education and work experience.
- Minimum of 2 years of work experience preferable in an Implantable Medical device, regulatory environment or pharmaceutical manufacturing.
- Must have fundamental knowledge of concepts, practices, and procedures of a particular field of specialization.
- Must possess good communication and analytical skills.
- Ability to work under deadlines.
- Demonstrated supervisory experience.
- Demonstrated use of Quality tools/methodologies.
- Solid communication and interpersonal skills.
- Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- Demonstrates technical leadership within the department and outside the department.
- 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 organizational and follow-up skills, as well as attention to detail.
- Ability to travel, including internationally.
Preferred Qualifications
- Credentials of a Certified Quality Engineer are a plus.
- Knowledge of GMP, ISO, FDA regulations, and quality systems auditing is desired.
- Experience working in a broader enterprise/cross-division business unit model
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.
The base pay for this position is
$66,700.00 – $133,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:NM Neuromodulation
LOCATION:United States > Texas > Plano : 6600 Pinecrest
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:Yes, 5 % of the Time
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)
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
Top Skills
What We Do
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 109,000 colleagues serve people in more than 160 countries.
