Quality Engineer II — Medical Device Process & CAPA

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

Benefits offered by this job

HIP medical plan

Tuition reimbursement

Retirement plan

Job summary

Abbott in Minnetonka, MN is seeking a Quality Engineer II to sustain and improve quality of electrophysiology products, ensuring manufacturing processes meet daily production schedules and regulatory requirements.

You will lead CAPA, risk analysis, and cross-functional collaboration to protect patient safety and support product quality. This role emphasizes problem solving and data-driven decisions in a fast-paced, matrixed environment.

Qualifications

• Bachelor’s Degree in engineering or technical field or equivalent
• 2–5 years engineering experience with quality tools/methodologies
• FDA, GMP, ISO 13485, ISO 14971 knowledge
• Ability to work in a matrixed, diverse environment
• Strong written and verbal communication skills
• Multitasks and meets deadlines
• Attention to detail and organizational skills

Responsibilities

• Identify and implement process control systems for qualification and manufacturing
• Lead in implementing assurances, process controls, and CAPA systems
• Develop and execute streamlined business systems to identify and resolve quality issues
• Apply systematic problem-solving to quality issues
• Collaborate with cross-functional teams to design experiments for process optimization
• Document experiment plans and results (protocols and reports)
• Lead process control and monitoring of CTQ parameters
• Lead product/process improvement methodologies (Six Sigma/Lean)
• Investigate and prevent non-conformances
• Support quality disciplines and act as Core Team Member
• Lead risk analysis completion and maintenance
• Support QMS/EMS and regulatory initiatives
• Maintain positive cross-level communications and collaboration

Skills

Communication

Time management

Attention to detail

Team player

Problem solving

Education

Bachelor’s degree in engineering/technical field

Job description

Abbott in Minnetonka, MN is seeking a Quality Engineer II to sustain and improve quality of electrophysiology products, ensuring manufacturing processes meet daily production schedules and regulatory requirements.

You will lead CAPA, risk analysis, and cross-functional collaboration to protect patient safety and support product quality. This role emphasizes problem solving and data-driven decisions in a fast-paced, matrixed environment.