298870 - Mfg Operations QA Manager at Medtronic

Ho Chi Minh City, Ho Chi Minh City, Vietnam

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, ManufacturingIndustries

Requirements

Bachelor’s degree in Quality Management, Industrial Management, or Engineering
Minimum 5–7 years of management experience in the pharmaceutical, medical device, or other highly regulated manufacturing industries, including at least 5 years in a Quality Manager role
Proven leadership with a strong track record in driving organizational and quality system improvements
Deep knowledge of Quality System Regulations, ISO standards (especially ISO 13485), and medical device industry standards
Extensive experience in auditing, QMS management, quality operations, and process improvement
Strong business acumen with solid operational, financial, and project management capabilities
Hands-on experience in managing projects and leading change initiatives
Excellent communication, influencing, problem-solving, and decision-making skills
Strong leadership in developing teams and managing talent effectively
Proficient in English (both written and spoken)
Management and supervisory experience with one or more employees, typically six or more direct reports, focused on tactical, operational, and some strategic activities

Responsibilities

Leads the manufacturing site toward excellence in product quality, operational performance, and a culture of putting patients first
Drives the integrated Quality and GOSC strategies to achieve results
Engages with and influences leaders across multiple teams, including Core Quality, Operating Units (OUs), and GOSC
Leads the QA function to ensure quality system development and compliance with FDA Quality System Regulation, ISO 13485/8, MDD, CMDR, and other applicable quality requirements
Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies and that the performance and quality of services meet established internal and external standards and guidelines
Leads audit and inspection preparation, manages the resolution of audit and inspection findings, and liaises with auditing groups and inspectors throughout all stages of the audit process
Promotes global standardization and best practice sharing to support the company’s mission worldwide
Develops, evaluates, implements, and maintains technical quality assurance and control systems or reliability systems and standards related to materials, techniques, and company products
Leads strategic planning within the function to drive continuous improvement and effectiveness of Quality Operations and Quality Systems
Coordinates activities with external suppliers and consultants to ensure timely delivery
Serves as CAPA Board Chair to ensure the effectiveness of the CAPA process and to drive the development of systems and processes for identifying, analyzing, correcting, and preventing quality issues
Acts as Management Representative to ensure the effectiveness and suitability of the Quality Management System
Represents the Ho Chi Minh site in OU/Enterprise Quality Leaders team meetings; collaborates with peers across sites and Operating Units on global quality initiatives; and works closely with other MDT sites on shared quality concerns

Skills

FDA QSR

ISO 13485

ISO 13485-8

MDD

CMDR

Quality Systems

CAPA

Audit Management

Inspection Preparation

Quality Assurance

Continuous Improvement

Strategic Planning

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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