Second-Shift Quality Engineer II – Process & CAPA Leader

Thornton Tomasetti; Minnetonka (MN); On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott is seeking a 2nd shift Quality Engineer II to support the Minnetonka, MN Electrophysiology division. You will work on qualification, CAPA, and process control initiatives to ensure regulatory compliance and product quality.

The role emphasizes cross-functional teamwork, documentation, and systematic problem solving in a fast-paced medical device environment. Abbott offers strong development and benefits.

Qualifications

• Bachelor’s Degree in engineering or technical field.
• 2–5 years engineering experience and demonstrated use of quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong verbal and written communications with ability to communicate at multiple levels.
• Multitasks, prioritizes, and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Responsibilities

• Identify and implement effective process control systems to support qualification and ongoing manufacturing.
• Lead in the implementation of assurances, process controls, and CAPA systems.
• Assist in development and execution of streamlined business systems to identify and resolve quality issues.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Work with cross functional teams to design and conduct experiments for process optimization.
• Document experiment plans and results, including protocol writing and reports.
• Lead process control and monitoring of CTQ parameters and specifications.
• Lead and implement Six Sigma and Lean Manufacturing initiatives.
• Lead investigation, resolution and prevention of product and process non-conformances.
• Participate in or lead teams supporting quality disciplines.
• Lead in the completion and maintenance of risk analysis.
• Support Quality Management Systems, Environmental Management Systems, and regulatory requirements.
• Complies with FDA regulations, other regulatory requirements, and company procedures.
• Maintains positive and cooperative communications across all levels.
• Ability to work 2nd shift hours.

Education

Bachelor’s Degree in engineering or Technical Field

Tools

Quality tools/methodologies

FDA/ISO quality systems

Job description

Abbott is seeking a 2nd shift Quality Engineer II to support the Minnetonka, MN Electrophysiology division. You will work on qualification, CAPA, and process control initiatives to ensure regulatory compliance and product quality.

The role emphasizes cross-functional teamwork, documentation, and systematic problem solving in a fast-paced medical device environment. Abbott offers strong development and benefits.