Sr Quality Systems Spec at Medtronic

Ho Chi Minh City, Ho Chi Minh City, Vietnam

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s degree, preferably in Engineering, Biomedical, or other relevant technical fields
At least 4+ years of practical experience in Quality Management within the medical device industry
Strong understanding of quality and regulatory system requirements such as ISO 13485 or GMP
Possessing an ISO 13485 Lead Auditor certification is a strong advantage
Demonstrated ability to apply practical knowledge and sound judgment to effectively manage and improve quality processes

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 assure compliance
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits
Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external
Co-ordinates legal requests in support of government investigations or litigations
Ensures the quality assurance programs and policies are maintained and modified regularly
Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally

Skills

Key technologies and capabilities for this role

Quality ManagementISO 13485GMPLead AuditorCorrective and Preventative ActionsAudit PreparationRegulatory ComplianceProcess Analysis

Questions & Answers

Common questions about this position

What compensation is offered for this Sr Quality Systems Spec role?

Medtronic offers a competitive salary and flexible benefits package. This position is also eligible for the Medtronic Incentive Plan (MIP), a short-term incentive.

Is this Sr Quality Systems Spec position remote or office-based?

This information is not specified in the job description.

What are the required qualifications and skills for this role?

A bachelor’s degree preferably in Engineering, Biomedical, or other relevant technical fields is required, along with at least 4+ years of practical experience in Quality Management within the medical device industry. Candidates need a strong understanding of quality and regulatory system requirements such as ISO 13485 or GMP, and ISO 13485 Lead Auditor certification is a strong advantage.

What is the company culture like at Medtronic?

Medtronic emphasizes a life-long career of exploration and innovation, leading with purpose to champion healthcare access and equity. The company fosters a connected, compassionate world, recognizes employee contributions, and shares in the success they create.

What makes a strong candidate for this Sr Quality Systems Spec position?

Strong candidates will have a bachelor’s degree in a relevant technical field, 4+ years in medical device Quality Management, deep knowledge of ISO 13485 or GMP, and preferably ISO 13485 Lead Auditor certification, along with demonstrated ability to manage and improve quality processes.

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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