Quality Systems Specialist at Medtronic

Taguig City, National Capital Region, Philippines

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s Degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or field related experience
Experience with medical device industry Regulations, Standards and Quality Management Systems
Intermediate or better level of experience with Microsoft suite, including but not limited to Word, Excel, SharePoint, Teams, PowerPoint and Adobe
Experience with Oracle Agile, Trackwise and/or PowerBI systems
Experience in FDA, Certifying Body and/or Notified Body audits/inspections
Experience or training in project management

Responsibilities

Supports 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
Conduct quality reviews of Change Orders for Quality Management System documents and records
Provides expertise and guidance to stakeholders in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
Supports 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, data analysis, etc. and provides to applicable stakeholders
Co-ordinates implementation of enterprise changes within local quality management system
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
Leads smaller quality projects and project teams, while facilitating larger quality projects in a variety of roles

Skills

Key technologies and capabilities for this role

Quality Management SystemQMSChange OrdersAudit PreparationInspection ResolutionRegulatory ComplianceData AnalysisQuality AssuranceCompliance PoliciesDocumentation

Questions & Answers

Common questions about this position

What education and experience are required for the Quality Systems Specialist role?

A Bachelor’s Degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or a related field is required, along with experience in the medical device industry regulations, standards, and quality management systems.

What specific software experience is needed for this position?

Intermediate or better experience with Microsoft suite (Word, Excel, SharePoint, Teams, PowerPoint, Adobe) is required, plus experience with Oracle Agile, Trackwise, and/or PowerBI systems.

Is audit and inspection experience necessary for this role?

Yes, experience in FDA, Certifying Body, and/or Notified Body audits/inspections is required.

What is the salary or compensation for this Quality Systems Specialist position?

This information is not specified in the job description.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

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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