Quality Engineer II

About the role

The Quality Engineer II position plays a crucial role in ensuring the quality and safety of medical devices produced by Abbott. This role involves developing and maintaining quality engineering methodologies, providing support during new product development, manufacturing, and system/service support, and addressing quality issues through various improvement methodologies.

Responsibilities

• Identify and implement effective process control systems to support the development, qualification, and ongoing 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.
• Aid 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 documenting experiment plans and results, including protocol writing and reports.
• Lead process control and monitoring of Critical-to-Quality (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 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.
• Collaborate with microbiology to ensure appropriate environmental monitoring and consider microbiology requirements 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.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Requirements

• Bachelor’s degree in Engineering or Technical Field/related degree.
• 2-5 years of engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO, 13485, and ISO.
• Strong communication and interpersonal skills.
• 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.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• 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 in a timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Qualifications

• Master’s degree preferred.
• Prior medical device experience preferred.
• ASQ CQE or other certifications preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.

Benefits

At Abbott, we offer comprehensive benefits to support your well-being and growth. These include:

• Career development with an international company where you can grow the career you dream of.
• 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 Freedom 2 Save student debt program, and FreeU 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.

Pay

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.