Engineer Sr., Quality at Abbott

Irvine, California, United States

Abbott Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Medical DevicesIndustries

Requirements

  • Minimum 5 years of experience (inferred from "Minimum 5 years o" – likely relevant quality engineering or supplier development experience)
  • Compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
  • Ability to maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Responsibilities

  • Contribute to the development, maintenance, and improvement of division supplier development quality program policies, procedures, and forms
  • Provide coaching and mentoring for technical team personnel
  • Provide guidance and training to Purchasing, R&D, Manufacturing, and Quality engineers in applying program requirements
  • Review and approve all supplied product drawings and component quality plans
  • Manage development of supplied product inspection procedures and first article requirements
  • Provide engineering guidance to division Receiving Inspection, including statistical analysis, measurement techniques, Gage R&R studies, and inspection procedures
  • Assess supplier capabilities through direct visits, technical discussions, directed testing, and quality system audits
  • Proactively communicate quality issues to suppliers through supplier quality system audits, supplier corrective action requests, and technical discussions
  • Participate and provide engineering ownership for all supplied product Non-Conforming Material Reviews
  • Contribute and participate in supplier performance reviews
  • Evaluate and develop Supplied Data Agreement partnerships with suppliers
  • Apply sound engineering analysis and judgment to reduce the need for inspection in accordance with program policies
  • Work with Manufacturing engineering to assess and address purchased product 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
  • Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member)

Skills

Supplier Quality Engineering
Supplier Selection
Supplier Evaluation
Material Qualification
Supplier Performance
Receiving Inspection
Quality Policies
Regulatory Compliance

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters
1888Year Founded
IPOCompany Stage
HealthcareIndustries
10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.
Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.
Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.
Abbott's microfluidic devices streamline diagnostic processes efficiently.
Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.
Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.
Significant investments indicate strong market confidence in Abbott's healthcare solutions.

Land your dream remote job 3x faster with AI