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 114,000 colleagues serve people in more than 160 countries.
Job Title
Quality Engineer II Overview
This position works out of our Minnetonka, MN 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. 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 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 Education and Experience
Bachelor's Degree in Engineering or Technical Field or equivalent experience Minimum 2-5 years engineering experience with demonstrated use of quality tools/methodologies Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971; solid communication and interpersonal skills Project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner 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; strong organizational and follow-up skills with attention to detail Preferred Experience
Master's Degree preferred Advanced computer skills, including statistical/data analysis and report writing; prior medical device experience preferred Experience implementing product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing); ASQ CQE or other certifications preferred Experience working in a broader enterprise/cross-division model preferred Compensation and Benefits
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. Learn more about our health and wellness benefits: www.abbottbenefits.com Equal Opportunity
Abbott is an Equal Opportunity Employer, committed to employee diversity.
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Quality Engineer II Overview
This position works out of our Minnetonka, MN 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. 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 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 Education and Experience
Bachelor's Degree in Engineering or Technical Field or equivalent experience Minimum 2-5 years engineering experience with demonstrated use of quality tools/methodologies Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971; solid communication and interpersonal skills Project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner 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; strong organizational and follow-up skills with attention to detail Preferred Experience
Master's Degree preferred Advanced computer skills, including statistical/data analysis and report writing; prior medical device experience preferred Experience implementing product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing); ASQ CQE or other certifications preferred Experience working in a broader enterprise/cross-division model preferred Compensation and Benefits
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. Learn more about our health and wellness benefits: www.abbottbenefits.com Equal Opportunity
Abbott is an Equal Opportunity Employer, committed to employee diversity.
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