CAPA Quality Systems Specialist at Medtronic

North Haven, Connecticut, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s Degree and 2 years of relevant experience OR Advanced Degree and 0 years of relevant experience
In-depth knowledge of FDA QSR, ISO 13485, and EU MDR (preferred)
Strong problem-solving, critical thinking, and analytical skills (preferred)
Excellent written and verbal communication skills (preferred)
Experience working in a cross-functional, matrixed environment (preferred)
ASQ certification (e.g., CQA, CQE, or CMQ/OE) (preferred)
Experience with Audit Management Systems (e.g., TrackWise, ETQ) (preferred)
Understanding of risk management (ISO 14971), software validation, or design control processes (preferred)
Prior experience supporting multiple site operations or global quality systems (preferred)

Responsibilities

Lead and support Quality System processes, such as CAPA (Corrective and Preventive Action), Internal Audits, Management Review, and Document Control
Serve as a subject matter expert (SME) for one or more Quality System elements in compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and other global regulations
Facilitate and support internal and external audits (e.g., FDA, Notified Body, ISO) including audit readiness activities, evidence preparation, and post-audit follow-ups
Partner cross-functionally to evaluate, improve, and harmonize quality system processes and procedures
Analyze and interpret quality system data to identify trends and recommend opportunities for improvement
Support and mentor junior team members in the interpretation and application of quality system requirements
Participate in global projects and initiatives, helping to drive standardization and best practices across sites

Skills

CAPA

FDA 21 CFR Part 820

ISO 13485

EU MDR

Internal Audits

Document Control

Audit Readiness

Quality System

Problem-Solving

Analytical Skills

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

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, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

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

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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