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:
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
Our Diagnostics business currently has an opportunity for a Design Quality Engineer in our Irving, TX office. The Design Quality Engineer will be responsible for using multidisciplinary engineering knowledge to design and develop innovative medical devices or components/subsystems in support of company's strategic plan.
What You’ll Work On
- Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
- Lead on-time completion of Design Control Deliverables.
- Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.
- Accountable for Design Verification and Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities.
- Lead or support Risk Management activities, including analyzing field data to support new product development, supporting Failure Mode Effects Analysis, generation of risk management plans/reports, and completion of hazard analysis.
- Support design test and inspection method development, and lead method validation activities.
- Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating, and resolving gaps.
- Support manufacturing process development and qualification for new product commercialization and product changes.
- Support internal and external audit responses and on-time product re-certifications.
- Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements.
- Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications.
- Support the development and review of biocompatibility and sterilization validations.
- Support the development and review of biocompatibility and sterilization validations.
- Complete Document Change Request Reviews in a timely and objective manner.
- Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Ensure compliance with procedural and documentation requirements of division, FDA, and ISO design controls.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
EDUCATION AND EXPERIENCE YOU’LL BRING
Minimum Qualifications
- Bachelor’s Degree, preferably in Mechanical, Chemical Engineering or Technical Field.
- Minimum 2 years of related experience.
Preferred Qualifications
- Manufacturing engineering experience. Medical device experience preferred.
- International manufacturing experience preferred.
- Six Sigma certification preferred.
- Strong analytical, problem solving and project management experience. Demonstrated leadership capability in team settings.
- 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.
- 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.
Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx. Follow your career aspirations to Abbott for diverse opportunities with a company that provides growth and strength to build your future. 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 Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$60,000.00 – $120,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:CRLB Core Lab
LOCATION:United States > Irving : LC-02
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:No
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting 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
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.
