Senior Quality Engineer

Abbott Laboratories; Los Angeles (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

HIP PPO medical

Tuition reimbursement

Great retirement plan

FreeU education benefit

Wellness program

Job summary

Abbott is seeking a Quality Engineer to develop and maintain quality engineering methodologies across NPD, manufacturing, and system/services support. You will lead process control, CTQ monitoring, and cross‑functional teams to ensure products meet internal and external requirements.

The role requires a Bachelor's in engineering, at least five years of experience, and knowledge of FDA, GMP, ISO 13485, ISO 14971.

Qualifications

• Bachelor's Degree in Engineering or Technical Field
• Minimum 5 years of experience; supervisory experience preferred
• Engineering experience with FDA, GMP, ISO 13485, ISO 14971
• Solid communication and interpersonal skills
• Strong project management and leadership abilities; cross‑functional teams
• Advanced computer skills including statistical data analysis and report writing
• Prior medical device experience; Six Sigma/Lean experience preferred
• ASQ CQE or other certifications preferred

Responsibilities

• Identify and implement effective process control systems for development, qualification, and manufacturing of products
• Lead, coach, and mentor staff
• Develop and execute streamlined business systems to resolve quality issues
• Apply systematic problem‑solving to identify and resolve quality issues
• Design and conduct experiments for process optimization/improvement
• Document experiment plans and results (protocols and reports)
• Lead process control and monitoring of CTQ parameters and specs
• Lead improvement methodologies (Six Sigma/Lean) and manage nonconformances investigations
• Participate in cross‑functional teams supporting quality decisions and practices
• Support risk analysis completion and maintenance
• Collaborate with design engineering on product verification/validation
• Work with microbiology on environmental monitoring and related requirements
• Support QMS/EMS and regulatory compliance initiatives
• Perform other related duties; develop SOPs and DWIs
• Coordinate with Distribution Centers on quality issues and nonconformance actions
• Support process development and new product introduction for externally manufactured products

Skills

Quality engineering

Process control

Six Sigma

Lean Manufacturing

Statistical analysis

Project management

Leadership

Communication

Education

Bachelor's degree in Engineering or technical field

Tools

ASQ CQE

Job description

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.

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• 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.

MAIN PURPOSE OF THE ROLE

This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

MAIN RESPONSIBILITIES

• 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

• Lead, coach, and mentor non-exempt and entry level exempt personnel

• Assist in the development and execution of streamlined business systems which effectively identify and resolve quality 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

• Appropriately document experiment plans and results, including protocol writing and reports

• Lead process control and monitoring of CTQ parameters and specifications

• Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)

• Lead the investigation, resolution and prevention of product and process nonconformances

• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)

• Lead in the completion and maintenance of risk analysis

• Work with design engineering in the completion of product verification and validation

• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities

• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

• Performs other related duties and responsibilities, on occasion, as assigned.

• Develop, lead and implement Standard Operating Procedure (SOP) and Detailed Work Instruction (DWI) for Business Unit and Process based on existing SOP and DWI

• Manage as primary contact with Distribution Centers regarding discussion of Quality Issue and help coordinate and lead Nonconformance and Corrective Actions for issues

• Support process development and new product introduction for externally manufactured product, component and accessories

QUALIFICATIONS

Education

• Bachelors Degree (± 16 years)in an Engineering or Technical Field or An equivalent combination of education and work experience

Experience/Background

• Minimum 5 years
• Demonstrated supervisory experience preferred.
• Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• 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
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Prior medical device experience preferred.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• 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 maintain regular and predictable attendance.
• ASQ CQE or other certifications preferred

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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 and @AbbottGlobal.

The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.