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Medtronic

Medical device maker advancing therapies

Operations Quality Engineer 2

Quality EngineeringUpdated on Nov 10
Full-timeNorth Haven, CT, USA$79.2k - $118.8k

About the Job

Requirements

  • A Bachelor's degree and at least 2 years of quality, manufacturing, or engineering experience, or a Master's degree and 0 years of quality, manufacturing, or engineering experience.
  • For a Baccalaureate degree earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Responsibilities

  • Support quality engineering initiatives that improve product quality, manufacturing performance, and quality system effectiveness.
  • Partner with manufacturing and engineering teams to establish, maintain, and enhance quality standards and control methods.
  • Develop and implement inspection, testing, validation, and monitoring strategies for products and production processes.
  • Analyze quality, process, and production data to identify trends, investigate issues, and drive corrective and preventive actions.
  • Execute root cause investigations and ensure effective implementation and verification of corrective actions.
  • Support regulatory, internal, and external audit readiness through compliant documentation and quality system execution.

Desired Qualifications

  • Experience in medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing environments, including supporting quality systems.
  • Knowledge of Quality System Regulation (QSR), ISO 13485, or other applicable quality standards.
  • Experience with process validation, test method validation, and/or equipment qualification activities.
  • Experience conducting root cause investigations, implementing corrective and preventive actions (CAPA), and analyzing quality/process data using statistical and problem-solving tools.
  • Experience supporting continuous improvement initiatives using Lean, Six Sigma, or similar methodologies; related certifications such as ASQ Certified Quality Engineer (CQE) or Six Sigma are preferred.
  • Experience collaborating with cross-functional manufacturing, engineering, quality, and operations teams.

About the Company

Medtronic

Medical device maker advancing therapies

Medtronic develops medical devices that diagnose, monitor, and treat chronic diseases. Its products include implantables, sensors, and therapies used in cardiovascular care, diabetes management, and neurostimulation, working by interacting with the body to regulate or monitor physiological processes. The company differentiates itself through a long history of device development, strategic acquisitions like Covidien, and a broad, diversified portfolio across therapeutic areas. Its goal is to improve patients’ health outcomes by delivering integrated medical technologies and solutions for disease management.

Company size
10,001+
Company stage
IPO
Headquarters
Fridley, MN
Founded
1949

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