Senior Quality Engineer – Neuromodulation & Pelvic Health

Regulatory Jobs

Minneapolis (MN)

On-site

USD 121,000 - 181,000

Full time

3 days ago

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Job summary

Medtronic is seeking a Principal Quality Engineer to lead Post Market Quality activities for Neuromodulation and Pelvic Health Service Depot operations in the U.S. This role drives investigations, CAPAs, risk assessments, and quality system processes to ensure safety, reliability, and effectiveness of therapies used by patients worldwide.

The ideal candidate has 7+ years in Quality Engineering or related fields, experience with CAPA and regulatory quality systems, and a track record of

Qualifications

Bachelor's degree and 7+ years of relevant experience in Quality Engineering, Manufacturing Engineering, Post Market Quality, Medical Device Quality, or a related quality-focused discipline; or Advanced degree with 5+ years of relevant experience.
Experience leading investigations involving product quality issues, customer complaints, nonconformances, or returned product evaluations.
Experience with CAPA processes and quality system requirements.
Knowledge of quality risk assessment methodologies and regulated quality system processes.
Experience working in a regulated industry environment.

Responsibilities

Serve as the primary Post Market Quality representative supporting Neuromodulation and Pelvic Health products within Service Depot operations, providing quality leadership and compliance oversight.
Lead complex investigations involving product quality issues, customer complaints, and returned product evaluations to identify root causes and drive effective resolution.
Evaluate post-market data, quality signals, and emerging risks to support strategic decision-making and ensure product performance expectations are met.
Lead the development and presentation of Product Performance Reviews, using trend analysis and quality metrics to communicate performance, risks, and improvement opportunities.
Own complex CAPAs and drive implementation of corrective actions that improve product quality, compliance, and operational effectiveness.
Identify and lead strategic quality improvement initiatives that enhance processes, reduce risk, and improve efficiency across Service Depot and repair operations.
Serve as a quality process owner and collaborate with cross-functional partners to ensure compliance with quality system requirements and continuous process improvement.