Quality Engineer (Risk Management)

Indotronix Avani Group; United States; On-site; Full time

Job summary

A leading company in the medical device sector is seeking a Quality Engineer III (Risk Management) to oversee compliance with risk management requirements. This role involves leading teams through product life cycles, ensuring safety and regulatory compliance, and developing risk management strategies. Ideal candidates will have extensive experience in regulated industries, particularly in medical devices, and hold relevant engineering degrees and certifications.

Qualifications

• 8+ years in a regulated industry, particularly in medical devices.
• 5+ years leading risk management concepts in medical devices.

Responsibilities

• Lead cross-functional discussions to identify and document hazards.
• Develop and maintain risk management plans for product development.
• Evaluate and document risk control methods.

Skills

Risk Management

Regulatory Compliance

Team Leadership

Education

Bachelor of Science degree in engineering

Master’s degree

Tools

ISO 14971

ISO 13485

IEC 60601

IEC 62304

Job description

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Indotronix Avani Group provided pay range

This range is provided by Indotronix Avani Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$70.00/hr - $78.00/hr

Job Title: Quality Engineer III (Risk Management)

Duration: 12 months

Job Description:

• The Quality Engineer-Risk Management is responsible for implementing and ensuring compliance with risk management requirements throughout all phases of the life cycle of the client's dispensing medical devices and solutions. They will lead cross-functional teams during the design and development and post-market risk management reviews to ensure that all necessary risk management activities are executed in accordance with the quality system.

Responsibilities:

• Lead cross-functional discussions with engineering, design, commercial, and product teams to ensure that all hazards associated with products are identified, risks are estimated, evaluated, controlled, and documented. Monitor that risk controls are implemented, verified, and validated for products in development and verify the effectiveness of risk control measures throughout the product life cycle.
• Develop, maintain, and execute risk management plans that support product development and ongoing sustaining activities in accordance with the client's risk management framework.
• Lead remediation efforts for updating risk management documents and the implementation of the FMEA process.
• Evaluate estimated risk and acceptability for each risk based on analysis outcomes, utilizing the client's risk acceptance criteria. If risks are not acceptable, lead efforts to identify and document risk control methods.

Required qualifications:

Knowledge, Skills & Abilities:

• Familiarity with risk management activities that support client's compliance with various international regulatory bodies, including ISO 14971 and ISO 13485. IEC 60601 and IEC 62304 experience is a plus.
• Experience in the medical device and/or regulated industry (required).

Minimum Educational Level:

• Bachelor of Science degree in engineering (Mechanical, Electrical, Materials, Biomedical, or related discipline), with a master’s degree preferred.
• Quality certifications relevant to clients, such as ASQ Certified Quality Engineering, Certified Auditor, and Six Sigma credentials, are preferred.
• 8+ years in a regulated industry, particularly within the medical device, bio-pharmaceutical, or biotechnology sectors, with a strong preference for experience at clients' or similar organizations.
• 5+ years leading and applying risk management concepts specifically within the context of medical devices ensuring high standards of patient and customer safety.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

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