Full-Time

Quality Engineer II

Manufacturing Operations

Posted on 4/8/2025

Medtronic

Medtronic

10,001+ employees

Develops and manufactures medical devices and therapies

Compensation Overview

$76k - $114k/yr

+ Short-term Incentive Plan (MIP)

Mid

North Haven, CT, USA

Category
QA & Testing
Quality Assurance
Requirements
  • Bachelor’s Degree AND minimum of 2 years related experience OR Advanced Degree with 0 years of experience
Responsibilities
  • Serve as the quality point of contact for manufacturing lines, providing guidance on quality issues and helping ensure day-to-day compliance.
  • Monitor and analyze process and product performance data to identify trends, drive root cause analysis, and support continuous improvement.
  • Lead or support nonconformance investigations, risk assessments, and corrective/preventive actions (CAPA) related to manufacturing processes.
  • Support validation of manufacturing processes, equipment, and cleaning procedures (IQ/OQ/PQ).
  • Review and approve work instructions, inspection plans, process changes, and deviations.
  • Participate in internal and external audits, ensuring readiness and effective response to findings.
  • Champion the use of Lean Six Sigma, statistical tools, and problem-solving methodologies.
  • Collaborate cross-functionally with operations, engineering, and supply chain to ensure product quality and operational efficiency.
Desired Qualifications
  • Knowledge of FDA QSR (21 CFR 820), ISO 13485, and GMP principles.
  • Experience with manufacturing process validations and quality assurance techniques.
  • Strong analytical and communication skills, with a collaborative and solutions-oriented mindset.
  • ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt certification.
  • Experience in a high-volume, highly regulated manufacturing environment.
  • Working knowledge of PFMEA, control plans, and statistical process control (SPC).
  • Familiarity with quality software systems (e.g., TrackWise, Agile, SAP, Minitab).

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals and healthcare professionals around the world. Medtronic stands out from competitors by not only focusing on product development but also offering comprehensive services such as training for healthcare providers and patient management programs. The company's goal is to enhance patient outcomes and lower healthcare costs through its advanced medical solutions.

Company Size

10,001+

Company Stage

IPO

Headquarters

Fridley, Minnesota

Founded

1949

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Simplify's Take

What believers are saying

  • Increased AI adoption in healthcare drives innovation in Medtronic's medical devices.
  • Growing demand for minimally invasive surgical instruments offers expansion opportunities for Medtronic.
  • Rising prevalence of chronic diseases boosts demand for Medtronic's cardiovascular and diabetes products.

What critics are saying

  • Recall of embolization devices may lead to reputational damage and financial losses.
  • AI-powered technologies face challenges related to data privacy and regulatory compliance.
  • Partnership with KIMS-Sunshine may encounter operational challenges affecting service delivery.

What makes Medtronic unique

  • Medtronic integrates AI to enhance diagnostic and treatment capabilities in medical devices.
  • The company offers a comprehensive suite of products and services for healthcare providers.
  • Medtronic's R&D capabilities support the development of tailored medical devices and therapies.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Company News

Content Media Solution
Apr 10th, 2025
KIMS-Sunshine, Medtronic Partner for Renal Denervation Therapy Center

Bengaluru, April 10, 2025: KIMS-Sunshine Hospital, one of Hyderabad's premier healthcare institutions has partnered with Medtronic, a global leader in medical technology to establish a specialized center for renal denervation therapy.

Like123
Apr 4th, 2025
'MythBusters' star Adam Savage explores longevity and life hacks: 'There's no magic secret'

Savage, now a YouTube creator and head of the channel Tested, has partnered with health technology company Medtronic to engage in discussions about longevity.

Just Business Solutions
Apr 3rd, 2025
'MythBusters' star Adam Savage explores longevity and life hacks: 'There's no magic secret'

Savage, now a YouTube creator and head of the channel Tested, has partnered with health technology company Medtronic to engage in discussions about longevity.

Synergy Health Bend
Apr 2nd, 2025
2025 Update on Automated Insulin Devices (AID)

Medtronic is working on an all-in-one, disposable sensor called Simpleta Sync.

MPO Magazine
Apr 2nd, 2025
Medtronic, Methinks AI Begin AI-Powered Stroke Care Collab

By integrating Methinks AI with Medtronic's stroke treatment portfolio, the duo hopes to streamline connectivity between stroke centers and regional hospitals.

INACTIVE