Senior Quality Engineer

Senior Quality Engineer

22 Nov 2024
California, Sylmar, 91342 Sylmar USA

Senior Quality Engineer

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 114,000 colleagues serve people in more than 160 countries.MAIN PURPOSE OF ROLEAbbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt 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 .

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 high employer contribution

Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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.

The OpportunityThis position works out of our Sylmar, CA location in the Cardiac Rhythm Management division.As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.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.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.

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.

Lead process control and monitoring of CTQ parameters and specifications.

Lead and implement various product and process improvement methodologies (i.e. Six Sigma and Lead Manufacturing).

Lead the investigation, resolution and prevention of product and process nonconformance's.

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

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

Perform other related duties and responsibilities, on occasion, as assigned.

Education and experience you will bring

Bachelors Degree (± 16 years)

Bachelor’s degree in Science, Engineering or a closely related discipline.

Minimum 5 years, both overall and any industry-specific experience needed.

Preferred Qualifications ASQ CQE or other certifications preferred. 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. Perform other related duties and responsibilities, on occasion, as assigned.The base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.An Equal Opportunity EmployerAbbot welcomes and encourages diversity in our workforce.We provide reasonable accommodation to qualified individuals with disabilities.To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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