Quality Engineer II

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

Benefits offered by this job

Free HIP PPO medical coverage

Great retirement savings plan with a高?

Tuition reimbursement and educationBEN

FreeU education benefit

Wellness program access

Job summary

Abbott in the United States > Sylmar: 15900 Valley View Court is seeking a senior Quality Engineer to develop and maintain quality methodologies across new product development and manufacturing. You will lead cross-functional teams and drive process improvements in a highly regulated environment.

The role emphasizes Six Sigma/Lean techniques, risk analysis, documentation, and collaboration with design and microbiology to ensure product quality from concept through release.

Qualifications

• Minimum 5 years of experience in quality/engineering roles.
• Demonstrated use of quality tools and methodologies.
• Knowledge of FDA, GMP, ISO 13485, ISO 14971.
• Strong communication and interpersonal skills.
• Led multi-departmental project teams and quality issue resolution.
• Advanced computer skills including statistical/data analysis and report writing.
• ASQ CQE or other certifications preferred.

Responsibilities

• Identify and implement process control systems for development and manufacturing.
• Lead, coach, and mentor personnel.
• Develop and execute streamlined business systems addressing quality issues.
• Apply systematic problem-solving methodologies to quality issues.
• Design and conduct experiments for process optimization.
• Document experiment plans and results, including protocols and reports.
• Lead process control and monitoring of CTQ parameters.
• Lead and implement product/process improvement methodologies (Six Sigma/Lean).
• Investigate, resolve and prevent nonconformances.
• Support quality disciplines and cross-functional teams in decisions and practices.
• Lead risk analysis activities and support product verification/validation.
• Collaborate with design engineering and microbiology to ensure environmental considerations.

Skills

Quality engineering

Six Sigma

Lean Manufacturing

Project management

Data analysis

Report writing

Communication skills

Cross-functional leadership

CQE certification (ASQ)

Education

Bachelor's Degree in Engineering or Technical Field

Tools

FDA GMP ISO knowledge

Statistical software

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.

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.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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

Travel

Yes, 10 % 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)

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