Abbott
Working At Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a high employer contribution
Tuition reimbursement, the student debt program, and 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Portland, OR location in the Heart Failure Division. In Abbott's Heart Failure (HF) business, we're developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. 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. What You'll Work On
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 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 methodologies (e.g., Six Sigma and Lean Manufacturing) Lead the investigation, resolution and prevention of product and process non-conformances 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 Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Required Qualifications
Bachelors Degree in Technical Field or Equivalent combination of education and work experience
2 years of related work experience
Preferred Qualifications
2-5 years Engineering experience and demonstrated use of Quality tools/methodologies
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
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
Medical device experience
Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
ASQ CQE or other certifications
The base pay for this position is $60,000.00
$120,000.00. In specific locations, the pay range may vary from the range posted.
At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a high employer contribution
Tuition reimbursement, the student debt program, and 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Portland, OR location in the Heart Failure Division. In Abbott's Heart Failure (HF) business, we're developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. 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. What You'll Work On
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 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 methodologies (e.g., Six Sigma and Lean Manufacturing) Lead the investigation, resolution and prevention of product and process non-conformances 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 Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Required Qualifications
Bachelors Degree in Technical Field or Equivalent combination of education and work experience
2 years of related work experience
Preferred Qualifications
2-5 years Engineering experience and demonstrated use of Quality tools/methodologies
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
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
Medical device experience
Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
ASQ CQE or other certifications
The base pay for this position is $60,000.00
$120,000.00. In specific locations, the pay range may vary from the range posted.