Quality Engineer

AgileGrid Solutions; États-Unis; Sur place; USD 79 000 - 119 000; Plein temps

Avantages offerts par ce poste

Bonus potential

Health insurance

401(k) contributions

Paid time off

Continuing education

Résumé du poste

Medline Industries, LP is seeking a post-market quality professional to independently manage activities that ensure medical device safety, effectiveness, and regulatory compliance. You will evaluate product performance, investigate complaints and adverse events, and lead CAPA initiatives under broad supervision.

The ideal candidate has a Bachelor’s degree in a technical field and at least two years of quality or engineering experience, with strong organizational and analytical skills and the

Qualifications

• Bachelor's degree in engineering, science, mathematics, or related technical field.
• At least two years of experience in quality or engineering.
• Ability to manage objectives with limited supervision and meet deadlines.
• Proficiency with Word, Excel, PowerPoint, Outlook; intermediate Excel skills including formulas, tables, conditional formatting, charts.

Responsabilités

• Manage post-market surveillance activities including complaint trending and adverse event monitoring.
• Conduct complaint investigations to determine reportability, root cause, and corrective actions.
• Support regulatory submissions (MDR, Vigilance) and maintain records for compliance.
• Develop and verify CAPAs addressing immediate risks and systemic causes.
• Collaborate with Regulatory Affairs, Medical Affairs, Operations, and Product Management on safety concerns and field actions.

Connaissances

Quality management

Regulatory knowledge

Analytical thinking

Project coordination

Problem solving

Formation

Bachelor's degree in engineering/science/mathematics

Outils

Microsoft Office

Description du poste

About The Company

Medline Industries, LP is a growing global organization focused on supporting healthcare providers and improving the delivery of care. Medline offers employees opportunities to contribute to meaningful work, develop their skills, and build careers in a collaborative environment. The company values continuous learning, inclusion, and professional growth while serving customers and communities around the world.

About The Company

Medline Industries, LP is a growing global organization focused on supporting healthcare providers and improving the delivery of care. Medline offers employees opportunities to contribute to meaningful work, develop their skills, and build careers in a collaborative environment. The company values continuous learning, inclusion, and professional growth while serving customers and communities around the world.

About The Role

Medline is seeking a post-market quality professional to independently manage activities that help ensure medical device safety, effectiveness, and compliance with applicable regulatory requirements and quality system standards. Under broad supervision, you will evaluate product performance in the field, investigate complaints and adverse events, identify emerging risks, and lead corrective and preventive action initiatives. You will use data and sound judgment to support timely decisions, escalating significant concerns when appropriate. This role requires strong organization, analytical thinking, and effective collaboration across functions.

Qualifications

A bachelor’s degree in engineering, science, mathematics, or a related technical field is typically required. Candidates must have at least two years of experience in quality or engineering and demonstrate the ability to manage objectives with limited supervision. You should be able to prioritize competing assignments, organize details, meet deadlines, solve problems systematically, and recognize when an issue requires escalation.

Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook, is required. Intermediate Excel skills should include working with formulas, tables, conditional formatting, and charts. Preferred candidates bring at least two years of experience in medical device complaint handling, post-market surveillance, MDR or Vigilance reporting, CAPA management, risk management, field actions, or quality systems. Familiarity with FDA 21 CFR Part 803, Part 820/QMSR, ISO 13485, EU MDR post-market requirements, and complaint investigation processes is highly desirable.

Responsibilities

Manage post-market surveillance activities, including complaint trending, adverse event monitoring, and review of product performance data. Conduct complaint investigations to determine reportability, root cause, and appropriate corrective actions. Support Medical Device Reporting (MDR), Vigilance Reports, and other global regulatory submissions, ensuring records are complete and reporting obligations are addressed.

Analyze complaint, audit, service, and field data to identify trends, evaluate risk, and recommend product or process improvements. Apply appropriate statistical techniques to support evidence-based decisions. Lead or support investigations involving nonconformances, complaints, adverse events, and field issues, and develop, implement, and verify CAPAs that address both immediate risks and systemic causes.

Partner with Regulatory Affairs, Medical Affairs, Operations, and Product Management to assess safety concerns and support field actions, recalls, health hazard evaluations, and regulatory inquiries as needed. Review complaint files, investigation documentation, CAPAs, and quality records for compliance with applicable FDA, ISO 13485, MDR, and other global requirements. Contribute quality metrics, trend reports, post-market surveillance summaries, and process effectiveness information to management reviews. Participate in internal and external audits and regulatory inspections concerning complaint handling, surveillance, reporting, and CAPA processes.

Benefits

The anticipated annual salary range is $79,000 to $119,000. Actual compensation may vary based on location, education, experience, skills, and abilities. This position may be eligible for bonus and/or incentive compensation. Medline will comply with applicable minimum wage and salary requirements. Employees working an average of 30 or more hours per week are eligible for benefits that include health insurance, life and disability coverage, 401(k) contributions, and paid time off. Employees working fewer than 30 hours per week may access 401(k) contributions, paid time off, the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp. Medline also offers continuing education and training, along with opportunities to grow within a worldwide organization.

Equal Opportunity

Medline is committed to creating a workplace where everyone can belong, contribute, and develop their career. The company seeks diversity, acts inclusively, and aims to provide employees with the tools and resources to perform at their best. Medline Industries, LP is an equal opportunity employer and evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.