JOB DESCRIPTION:Quality Engineer
The OpportunityThis position works out of our
San Diego, CA location in the
Infectious Disease, Diagnostics Division. We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.
The
Quality Engineer is responsible for developing and maintaining quality systems and providing quality system support for the division (e.g. commercialized products, new product development, manufacturing, and/or system compliance).
What You'll Work On- Provides Quality System Body of Knowledge support to Division and organization.
- Implements and conducts data analysis, systems evaluation, and product assessment to ensure finished products meet standards and specifications; implement and drive changes where needed.
- Investigates, and resolves system nonconformance's (defined during internal and/or external audits.
- Works with product development and production engineers during product development process to ensure quality deliverables (FMEA, Control Plans, Risk Management) are in place prior to Design Transfer phase gate.
- Ensures compliance with ISO 13485 & 21CFR 820 Quality System Regulations by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represents the Quality System function as a Team Member)
- As appropriate, Six Sigma utilizes 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 or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
- As appropriate, participate in or lead in the completion and maintenance of risk analysis, as related to quality systems.
- 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.
Required Qualifications- Bachelors in Engineering or Technical Field, or an equivalent combination of education and work experience.
- Minimum of 2 years technical experience.
Preferred Qualifications- Masters Degree preferred.
- Two - Five years technical experience. Previous Quality experience and demonstrated use of Quality Tools/methodologies.
- Detailed knowledge of FDA, GMP, and ISO 13485. Solid communication and interpersonal skills.
- 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.
- Advanced computer skills, including gap analysis and report writing skills.
- Prior medical device experience preferred. Six Sigma certification preferred. ASQ CQE, CQA certification preferred.
- Experience working in a broader enterprise/cross division business unit model preferred.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Ability to travel approximately 10-25%, including internationally.
Apply NowLearn 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.
The base pay for this position is $81,500.00 - $141,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:ID Infectious Disease
LOCATION:United States > San Diego : 4545 Towne Center Court
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 25 % 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), Keyboard use (greater or equal to 50% of the workday), Work requiring repeated bending, stooping, squatting or kneeling
