

New · posted Nov 11
Abbott · Medical Devices
Senior Engineer Supply Development Quality
- Irving, TX
- On-site
- Full-time
- Senior & Principal
The role
Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements.
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 122,000 colleagues serve people in more than 160 countries.
What you need
Required Qualifcations
- Bachelor's Degree in a relevant field
- Minimum of five (5) years of relevant experience in a medical device or pharmaceutical field
- Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
- 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
- Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing).
- CAPA Experience
Preferred Qualificationsnice to have
- Masters Degree
- Experience working in a broader enterprise/cross-division business unit model preferred.
- ASQ CQE or other certifications preferred
- Prior medical device experience
What you'll do
What You'll Work On
- Contributes to the development, maintenance and improvement of division supplier development quality program policies, procedures and forms.
- May provide coaching, and mentoring for technical team personnel.
- Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements.
- Reviews and approves all supplied product drawings and component quality plans.
- Manages development of supplied product inspection procedures and first article requirements.
- Provides engineering guidance to division Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.
- Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits.
- Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions.
- Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews.
- Contributes and participates in supplier performance reviews.
- Evaluates and develops Supplied Data Agreement partnerships with suppliers.
- Applies sound engineering analysis and judgment to reduce the need for inspection in accordance to program policies.
- Works with Manufacturing engineering to assess and address purchased product issues.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Design and conduct experiments for process optimization and/or improvement
- Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member)
- 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.
Pay and benefits
$78,000 – $156,000 a year
Employer providedThe base pay for this position is
$78,000.00 – $156,000.00
In specific locations, the pay range may vary from the range posted.
Free medical coverage through Health Investment Plan PPO
Retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit
Career development
Where you'll work
Irving, TXOn-siteOpen in Maps (opens in a new tab)
More jobs in Irving, TXWorking conditions
Standard
TRAVEL
Yes, 10 % of the Time
MEDICAL SURVEILLANCE
Not Applicable
JOB FAMILY
Operations Quality
DIVISION
CRLB Core Lab
LOCATION
United States > Irving : LC-8

From the posting
About Abbott
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 by Fortune.
- A company that is recognized as one of the best big companies to work for and a best place to work for diverse, working mothers, female executives, and scientists
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% below the US median for Supplier Quality roles at this level.
This roleEmployer provided
Senior & Principal roles in the US37 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $78,000 | — | $156,000 |
| All US (middle half) | $111,500 | $119,000 | $137,500 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Supplier Quality roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Supplier Quality
The general path across 87 open Supplier Quality roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Career resources on Supplier Quality
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk9
- GMP and compliance8
- Collaboration and leadership8
- Lab testing and methods4
- Documentation and SOPs4
- Investigations and CAPA2
- Validation and qualification1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Supplier Quality work in medical devices, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devicesNamed in the posting
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirements
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- ISOISO 11135(official source, opens in a new tab)Ethylene oxide sterilization of health care products
- ISOISO 11137-1(official source, opens in a new tab)Radiation sterilization of health care products
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
Company hiring pulse
Abbott on Regulatory Jobs
- 117
- Open roles
- 117
- Distinct roles
- 34
- Locations
By discipline
- Quality62 53%
- Regulatory30 25%
- Clinical25 21%
By level
- Senior & Principal57 48%
- Associate & Specialist33 28%
- Manager25 21%
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Senior Engineer Supply Development Quality at Abbott
Applications close December 7. $78K–$156K a year, employer provided.


