Quality Engineer II

Abbott

Los Angeles (CA)

On-site

USD 90,000 - 180,000

Full time

14 days+

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Benefits offered by this job

Free medical coverage

Retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott is seeking a seasoned Quality Engineer to develop and maintain quality engineering methods across new product development, manufacturing, and systems support. The role emphasizes process control, problem solving, and cross-functional leadership.

Requirements include a Bachelor’s in engineering, 5+ years of experience, and knowledge of FDA, GMP, ISO standards. Strong communication and project management skills are essential as you drive quality improvements in a matrixed environment.

Qualifications

Bachelors Degree in Engineering or Technical Field or equivalent combination of education and experience.
Experience with quality engineering in medical devices and manufacturing.
Familiarity with FDA, GMP, ISO 13485, ISO 14971 required or preferred.

Responsibilities

Identify and implement effective process control systems to support development, qualification, and manufacturing.
Lead, coach, and mentor personnel across levels.
Assist in development and execution of streamlined business systems to identify and resolve quality issues.
Apply systematic problem-solving to prioritize and resolve quality issues.
Design and conduct experiments for process optimization and improvement.
Document experiment plans and results, including protocols and reports.
Lead process control and monitoring of CTQ parameters and specifications.
Lead quality improvement methodologies (Six Sigma, Lean) implementations.
Investigate, resolve, and prevent product/process nonconformances.
Participate in cross-team quality decisions and practices as Core Team member.
Maintain risk analysis and support product verification/validation with design.

Skills

Supervisory experience

Quality tools/methodologies

FDA GMP ISO 13485 ISO 14971

Statistical data analysis

Project management

Communication skills

Education

Bachelor's Degree in Engineering or Technical Field

Tools

Six Sigma

Lean Manufacturing

Job description

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.

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, 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.

JOB FAMILY:

Operations Quality

DIVISION:

CRM Cardiac Rhythm Management

LOCATION:

United States > Sylmar : 15900 Valley View Court

WORK SHIFT:

Standard