Engineer, Sr. Quality Assurance

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 109,000 colleagues serve people in more than 160 countries.

About Abbott

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 107,000 colleagues serve people in more than 160 countries.

Our Neuromodulation business is an area of expertise for Abbott. This business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. Our Solutions include Proclaim (TM) XR SCS System, the #1 Spinal cord stimulator on the market, Proclaim (TM) DRG Neurostimulator, the only FDA approved DRG therapy and a market leader in radiofrequency ablation therapy, Abbott RFA. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Our deep brain stimulation technology for progressive diseases help people manage their Parkinson's disease and essential tremor symptoms, steering away from side effects.

Our location in Plano,TX currently has an opportunity for a Sr. Engineer (Operational Excellence Program Lead). Responsible for driving cultural change through molding the continuous improvement and root cause problem solving mindset of the organization. Working closely with the cross functional Value Stream teams, this position will design, develop, standardize, and implement Operations methods intended to continuously improve manufacturing system performance and culture.

WHAT YOU'LL DO:

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 in the implementation of assurances, process controls, and CAPA systems designed 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 Quality 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 methodologies (e.g., Six Sigma, Kaizen and Lean Manufacturing)

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

Lead in the completion and maintenance of risk analysis

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

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

Support internal and external inspections

Analyze Quality System data and present established metrics to senior and executive management

Education: Bachelors Degree Engineering or Technical Field

Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, EUMDR 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. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).

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).

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