New · posted Nov 8
Abbott · Medical Devices
Senior Development Quality Engineer
- Sylmar, CA
- On-site
- Full-time
- Senior & Principal
The role
Main Purpose of the Role
The Senior Development Quality Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
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
Qualification
- Bachelors Degree (± 16 years) - Engineering or Technical Field or an equivalent combination of education and work experience
- Masters Degree (± 18 years) - Preferred
Experience / Background
- Minimum 5 years
- Previous Quality engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, and ISO 13485
- Solid communication and interpersonal skills. 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. Advanced computer skills, including statistical/data analysis and report writing skills.
- Prior medical device experience preferred. ASQ CQE certification preferred. Design for Six Sigma and Critical to Quality training and experience preferred.
- 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. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 10%, including internationally.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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.
Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.
What you'll do
Main Responsibilities 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 & execution, including active cross-functional root-cause analysis investigation & resolution activities
- Lead Risk Management activities from product Concept through Commercialization
- Lead design test and inspection method development, and lead method validation activities
- Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
- Support manufacturing process development & qualification for new product commercialization and product changes
- Support/lead and ensure internal & external audit responses
- Support/lead and ensure 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
- Accountable for development, execution and analysis of biocompatibility and sterilization qualifications
- Complete Document Change Request Reviews in a timely and objective manner
- Develop and lead other team members.
- Perform other duties and responsibilities as assigned by management.
- Support/lead 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.
- 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
$90,000 – $180,000 a year
Employer providedThe base pay for this position is
$90,000.00 – $180,000.00
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
Sylmar, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Sylmar, CAWorking conditions
Standard
TRAVEL
Yes, 10 % of the Time
MEDICAL SURVEILLANCE
Not Applicable
JOB FAMILY
Operations Quality
DIVISION
CRM Cardiac Rhythm Management
LOCATION
United States > Sylmar : 15900 Valley View Court
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 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.
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
Abbott is an Equal Opportunity Employer, committed to employee diversity.
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 8, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% above the US median for Design Quality & Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California17 roles publishing pay
Senior & Principal roles in the US47 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $90,000 | — | $180,000 |
| California (middle half) | $128,000 | $135,000 | $146,000 |
| All US (middle half) | $115,000 | $128,000 | $134,500 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Design Quality & Assurance roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Design Quality & Assurance
The general path across 71 open Design Quality & Assurance roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership15
- GMP and compliance7
- Documentation and SOPs4
- Quality systems and risk4
- Validation and qualification3
- Lab testing and methods2
- Investigations and CAPA1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Design Quality & Assurance work in medical devices, led by the two 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 devices
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA human factors guidance(official source, opens in a new tab)Applying human factors and usability engineering to medical devices
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipment
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
Company hiring pulse
Abbott on Regulatory Jobs
- 111
- Open roles
- 111
- Distinct roles
- 34
- Locations
By discipline
- Quality59 53%
- Regulatory30 27%
- Clinical22 20%
By level
- Senior & Principal53 47%
- Associate & Specialist32 29%
- Manager24 21%
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Senior Development Quality Engineer at Abbott
Open until filled. $90K–$180K a year, employer provided.