Senior Quality Engineer - Risk Management (Remote)

MillenniumSoft Inc; San Diego (CA); Remote; USD 90,000 - 120,000; Full time

Job summary

A leading company in medical devices is seeking a Senior Quality Engineer specializing in Risk Management. This remote role involves ensuring compliance with risk management throughout the product lifecycle, leading cross-functional teams, and mentoring team members. Ideal candidates will have extensive experience in regulated industries and a strong background in risk management processes.

Qualifications

• 8+ years in regulated industry.
• Experience leading risk management in medical devices.

Responsibilities

• Lead discussions to identify hazards and document risks.
• Develop and maintain risk management plans.
• Provide training on standards and processes.

Skills

Communication

Data Analysis

Education

Bachelor's in Engineering

Master's

Tools

Pyxis

Job description

Senior Quality Engineer - Risk Management (Remote)

Join to apply for the Senior Quality Engineer - Risk Management (Remote) role at MillenniumSoft Inc.

Position Details

• Experience: 8+ years in regulated industry
• Location: San Diego, CA
• Duration: 12 months
• Hours per week: 40
• Shift: 1st shift
• Client: Medical Devices Company
• Category: Engineering
• Level: Entry Level
• Employment: Contract on W2 (US Citizens, GC Holders, GC EAD, OPT, EAD, CPT)

Job Description

The Contract Engineer - Risk Management is responsible for implementing and ensuring compliance with risk management requirements throughout all phases of the lifecycle of client dispensing medical devices and solutions. They will lead cross-functional teams during design, development, and post-market reviews to ensure all risk management activities are executed per the quality system, covering risks like data integrity, system security, electricity, moving parts, and usability. The role involves leading and coaching teams on risk management processes to support innovation and patient safety.

Responsibilities

• Lead cross-functional discussions to identify hazards, estimate, evaluate, control, and document risks; monitor risk controls in development and verify their effectiveness throughout the product lifecycle.
• Develop and maintain risk management plans supporting product development and ongoing activities.
• Lead reviews of risk management processes and quality system deliverables to ensure effectiveness and compliance.
• Lead remediation efforts for updating risk management documents and implementing FMEA processes.
• Evaluate and accept risks based on analysis outcomes and client criteria; lead efforts to identify and document risk control methods for unacceptable risks.
• Support Benefit-Risk Analysis and evaluate overall residual risk aligned with strategic objectives.
• Perform and document Risk Reviews to communicate results across teams.
• Ensure harmonization of risk strategies across projects and lifecycle stages.
• Identify opportunities for process improvements.
• Provide training on standards and processes.
• Assist with strategic initiatives and planning.
• Mentor team members on risk management processes.

Required Qualifications

• Knowledge of risk management activities supporting compliance with ISO 14971, ISO 13485; IEC 60601 and IEC 62304 experience is a plus.
• Experience in medical device or regulated industry.
• Experience with remediation and FMEA processes in medical devices.
• Ability to analyze data from proprietary sources to calculate risk levels.
• Strong communication skills for cross-team collaboration.
• Technical experience with Pyxis or automated dispensing cabinets is preferred.

Educational and Experience Requirements

• Bachelor's in engineering (Mechanical, Electrical, Materials, Biomedical); Master's preferred.
• Relevant certifications like ASQ CQE, Auditor, Six Sigma preferred.
• 8+ years in regulated industry; 5+ years leading risk management in medical devices.

Additional Details

• Senior Level: Mid-Senior
• Employment Type: Contract
• Job Function: Quality Assurance
• Industry: Staffing and Recruiting