2nd-Shift Quality Engineer II – Medical Devices

Abbott

Minnetonka (MN)

On-site

USD 61,000 - 123,000

Full time

9 days ago

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Benefits offered by this job

Free medical coverage

Competitive retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott in Minnetonka, MN is seeking a 2nd shift Quality Engineer II to support the Electrophysiology product line. You will ensure manufacturing processes meet schedules while improving productivity and product quality, and you will uphold FDA, GMP, ISO requirements.

The role requires collaboration with cross-functional teams, CAPA ownership, and risk analysis. The shift is Monday–Thursday 2:30 PM–12:30 AM CST with occasional overtime on Fridays, and Abbott offers strong benefits, tuition

Qualifications

Bachelor's degree in engineering or equivalent.
2-5 years of engineering experience with FDA, GMP, ISO 13485 and ISO 14971 knowledge.
Ability to work in a matrixed, fast-paced environment.

Responsibilities

Identify and implement effective process controls to support qualification and ongoing manufacturing.
Lead CAPA systems to meet internal and external requirements.
Develop and execute streamlined systems to identify and resolve quality issues.
Apply systematic problem-solving to prioritize and resolve quality issues.
Collaborate with cross-functional teams to design experiments for process optimization.
Document experiment plans and results, including protocol writing and reports.
Lead risk analysis and monitor CTQ parameters.
Support quality disciplines and regulatory requirements.