Sr. Quality Systems Manager at Medtronic

North Haven, Connecticut, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Technology, HealthcareIndustries

Requirements

Bachelor’s Degree
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 4 years relevant experience
Effective usage of data analysis tools, analytical and research skills, and problem-solving techniques with keen attention to detail and simultaneous understanding of the "big picture"
Desire to follow an audit trail to identify risks, non-conformances, true root cause, etc
Outstanding written, oral communication, and presentation skills
Sound judgement, ability to make decisions, work independently, and demonstrated leadership skills
Ability to manage and execute on multiple critical projects simultaneously
Capable to manage multiple priorities and escalate issues
Excellent writing and editing skills, and computer skills
Demonstrated knowledge of applicable Quality, FDA (Food & Drug Administration) Medical Device Directives/Regulation and ISO (International Organization for Standardization)
Travel within US and International approximately 25%

Responsibilities

Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance
Responsible for communicating business-related issues or opportunities to next management level
Lead, coordination and preparation of internal and external audits, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits
Own and drive Investigations, Root Cause Analysis and resultant Corrective Actions and Preventive Actions
Perform trend analyses and report compliance observations to identify areas in need of improvement
Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc

Skills

Key technologies and capabilities for this role

Quality SystemsRegulatory ComplianceAuditsRoot Cause AnalysisCAPATrend AnalysisInvestigations

Questions & Answers

Common questions about this position

What are the minimum education and experience requirements for this role?

A Bachelor’s Degree is required along with a minimum of 7 years of relevant experience, or an advanced degree with a minimum of 4 years of relevant experience.

Is travel required in this position?

Yes, travel within the US and internationally is approximately 25%.

What key skills are needed for the Sr. Quality Systems Manager role?

Required skills include effective usage of data analysis tools, analytical and research skills, problem-solving techniques, outstanding written, oral communication, and presentation skills, sound judgement, ability to work independently, and demonstrated leadership skills.

What is the company culture like at Medtronic?

Medtronic emphasizes a mission-driven culture focused on innovation, healthcare access and equity, professional growth through training and mentorship, and transforming healthcare in a connected, compassionate world.

What makes a strong candidate for this position?

Strong candidates will have demonstrated knowledge of Quality, FDA Medical Device Directives/Regulation and ISO standards, excellent writing and editing skills, computer skills, and experience leading audits, investigations, root cause analysis, and corrective actions.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free