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Medtronic

Medical device maker advancing therapies

Quality Engineer 2

Quality EngineeringUpdated on Nov 13
Full-timeNorth Haven, CT, USA$79.2k - $118.8k

About the Job

Requirements

  • A bachelor's degree in Engineering, Science, or a technical field and at least 2 years of Engineering and/or Quality experience, or an advanced degree in Engineering, Science, or a technical field with no Engineering and/or Quality experience.
  • Preferred: A bachelor's degree in Chemical, Biomedical, or Mechanical Engineering; an advanced degree is also preferred.
  • Manufacturing environment experience is preferred.
  • Process validation experience across the validation lifecycle, including Installation Qualification (IQ), Operational Qualification (OQ), Test Method Validation (TMV), and Performance Qualification (PQ), is preferred.
  • Corrective and Preventive Action (CAPA) experience is preferred.
  • Experience with Minitab statistical software and/or Six Sigma training is preferred.

Responsibilities

  • Develop, apply, and maintain quality standards and protocols for manufacturing processes and products.
  • Execute process validation activities across the validation lifecycle, supporting compliant and reliable manufacturing processes.
  • Partner with Engineering and Manufacturing to establish and maintain quality standards and resolve product and process quality issues.
  • Develop and implement inspection, testing, and evaluation methods for products, materials, processes, and production equipment.
  • Perform quality assurance testing and statistical analysis to evaluate process and product performance.
  • Investigate nonconforming products or materials and support corrective and preventive action (CAPA) activities.
  • Ensure corrective measures meet reliability standards and associated quality documentation complies with requirements.
  • Support quality activities across production control, product evaluation, reliability, incoming materials, and process quality.

Desired Qualifications

  • A bachelor's degree in Chemical, Biomedical, or Mechanical Engineering; an advanced degree is preferred.
  • Manufacturing environment experience.
  • Process validation experience across the validation lifecycle, including Installation Qualification (IQ), Operational Qualification (OQ), Test Method Validation (TMV), and Performance Qualification (PQ).
  • Corrective and Preventive Action (CAPA) experience.
  • Experience with Minitab statistical software and/or Six Sigma training.

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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