Sr. Engineer Risk Mgmt

Medline; United States; On-site; USD 92,000 - 138,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Disability insurance

401(k) contributions

Paid time off

Employee benefits

Job summary

Medline Industries, LP seeks a senior lead contributor to create, monitor, maintain and enhance risk controls by analyzing quality data and major quality events to ensure global risk management across medical devices, cosmetics, and OTC drugs.

You will collaborate with clinical, design engineering, regulatory, labeling and international partners to mitigate, disclose, and monitor risk; provide expertise, education, and support; and implement risk controls compliant with EU MDR, FDA, ISO 13485

Qualifications

• Bachelor degree in biology, chemistry, engineering or statistics-based field.
• 4+ years QA/QE in a cGMP device environment.
• 2+ years risk management related to FDA regulated products.

Responsibilities

• Create and align global risk management processes for consistent risk analysis.
• Evaluate risks and approve Change Controls, FMEA, MDR, Recalls, HHEs and other events.
• Communicate risks to senior global management and build cross‑functional relationships.
• Lead cross‑department collaboration globally with R&D, Manufacturing and other sites.
• Develop systems to analyze multiple data streams for health of quality/risk systems.
• Work with SMEs to build a framework for risk-based dashboards for real‑time decisions.
• Provide inputs on implementing controls and identify inefficiencies in the global quality system.
• Lead deadlines, monitor progress, and suggest schedule improvements.

Skills

Project management

Prioritization

Oral & written communication

Independent & collaborative work

FDA, GMP, ISO 13485, ISO 14971

FMEA facilitation

Education

Bachelor of Science in Biology/ Chemistry/ Engineering/ Statistics

Master's degree (preferred)

Job description

Job Summary

This role will be the senior lead contributor within the organization that creates, monitors, maintains, and enhances risk controls by analyzing quality data and major quality events to ensure Medline is properly controlling risks on a global level for medical devices, cosmetics, and OTC drugs.

This individual will collaborate with clinical, design engineering, regulatory, labeling, and international partners to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. Provide expertise to the organization including education, technical support, issue resolution, and integration of new or enhanced risk controls to be compliant with EU MDR along with satisfying FDA, ISO 13485, and ISO 14971 risk management related processes throughout the product life cycle.

Job Description

MAJOR RESPONSIBILITIES

• Create and align global risk management processes to ensure that risks are being analyzed consistently.
• Evaluate the risks and act as an approver for the following processes: Change Controls, Failure Mode Effect Analysis (FMEA), Medical Device Reporting (MDR), Recalls, Health Hazard Evaluations (HHEs), and other major quality events.
• Effectively communicate risks to senior global management. Build effective relationships with quality and business partners.
• Lead cross-department collaboration with R&D, Manufacturing, and other sites on a global level to ensure all risks are adequately addressed with robust risk controls.
• Create and manage systems to analyze multiple streams of data to gauge the health of a quality or risk management system.
• Work with Subject Matter Experts (SMEs) to create a framework for Risk-based dashboards to be used for real-time decision-making and management reporting.
• Provide detailed input to stakeholders on how to implement risk controls as well as create and implement controls.
• Identify inefficiencies in Medline's global quality management system. Take action to address identified inefficiencies.
• Lead and ensure that deadlines and goals are being met.
• Frequently update management and team on progress.
• Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve timelines for project completion.

MINIMUM JOB REQUIREMENTS

Education

Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics-based degree.

Work Experience

• At least 4 years of QA/QE experience in a cGMP Device or environment.
• At least 2 years of direct risk management experience related to FDA regulated products.
• Experience creating quality sub-systems and leading complex projects.

Knowledge / Skills / Abilities

• Ability to manage 5+ projects at a time.
• Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills and the ability to work independently and as a team in an efficient manner.

PREFERRED JOB REQUIREMENTS

Education

Masters of Science - Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field.

Work Experience

• At least 5 years of QA/QE experience in a cGMP Device or environment.
• Certification - Six Sigma certification.

Knowledge / Skills / Abilities

• Working understanding of FDA, GMP, ISO 13485, and ISO 14971.
• Experience facilitating FMEAs - Systems or clinical engineering experience.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:
$92,000.00 - $138,000.00 Annual

The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here .

We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here .

Medline Industries, LP is an equal opportunity employer. Medline 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,