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Abbott

Makes heart devices, glucose sensors and lab tests

Senior Development Quality Engineer

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timeSylmar, Los Angeles, CA, USA$90k - $180k

About the Job

Requirements

  • A bachelor's degree in engineering or a technical field, or an equivalent combination of education and work experience, is required.
  • A minimum of five years of experience is required.
  • Previous quality engineering experience and demonstrated use of quality tools and methodologies are required.
  • Detailed knowledge of FDA regulations, good manufacturing practices, and ISO 13485 is required.
  • Project management and leadership skills are required, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
  • Advanced computer skills are required, including statistical and data analysis and report writing skills.
  • The ability to work in a highly matrixed and geographically diverse business environment is required.
  • The ability to work within a team and as an individual contributor in a fast-paced, changing environment is required.
  • The ability to leverage and engage others to accomplish projects is required.
  • The ability to communicate verbally and in writing with multiple levels of the organization is required.
  • The ability to multitask, prioritize, meet deadlines, and demonstrate strong organizational, follow-up, and attention-to-detail skills is required.
  • The ability to travel approximately 10%, including internationally, is required.
  • Compliance with U.S. Food and Drug Administration regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments is required.

Responsibilities

  • Lead on-time completion of design control deliverables.
  • Create quality plans and ensure their on-time execution for internal development, original equipment manufacturer-based, clinical product development, and design change projects.
  • Be accountable for design verification and validation planning and execution, including active cross-functional root-cause analysis, investigation, and resolution activities.
  • Lead risk management activities from product concept through commercialization.
  • Lead design test and inspection method development and method validation activities.
  • Ensure design history file content completion, integrity, and regulatory and standards compliance, and collaboratively communicate and resolve gaps.
  • Support manufacturing process development and qualification for new product commercialization and product changes.
  • Support or lead audit responses and ensure they are completed.
  • Support or lead product recertifications and ensure they are completed on time.
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications.
  • Be accountable for the development, execution, and analysis of biocompatibility and sterilization qualifications.
  • Complete document change request reviews in a timely and objective manner.
  • Develop and lead other team members.
  • Perform other duties and responsibilities as assigned by management.
  • Support or lead company initiatives identified by management in support of quality management systems, environmental management systems, and other regulatory requirements.
  • Maintain positive and cooperative communication and collaboration with employees at all levels, customers, contractors, and vendors.

Desired Qualifications

  • A master's degree is preferred.
  • Prior medical device experience is preferred.
  • ASQ Certified Quality Engineer certification is preferred.
  • Design for Six Sigma and Critical to Quality training and experience are preferred.
  • Experience working in a broader enterprise or cross-division business unit model is preferred.

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size
10,001+
Company stage
IPO
Headquarters
Abbott Park, IL
Founded
1888

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