Quality Engineer 3

Company : Katalyst Healthcares & Life Sciences

Job Description:

• The Contract Engineer Risk Management is responsible for implementing and ensuring compliance with risk management requirements throughout all phases of the life cycle of 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.
• This includes, but is not limited to, risks associated with medical devices such as data integrity, systems security, electricity, moving parts, and usability.
• The role will lead and coach cross-functional teams on risk management processes that support client's commitment to innovation and patient safety.

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 client's risk management framework.
• Lead periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and document decisions and actions taken, aligned with client's quality systems and ensuring compliance with regulatory standards and practices.
• 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 client's risk acceptance criteria. If risks are not acceptable, lead efforts to identify and document risk control methods.
• Support the Benefit-Risk Analysis process and lead the evaluation of overall residual risk, ensuring alignment with client's strategic objectives.
• Perform and document Risk Reviews to communicate results of the risk management process to cross-functional teams.
• Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk team members.
• Identify opportunities for continuous improvement of the Risk Management Process.
• Facilitate and provide ongoing training on standards/processes as needed to other associates or functions.
• Assist with strategic initiatives and planning.
• Mentor and coach other members on the team and cross-functional teams on risk management processes.

Requirements:

• 8+ years in a regulated industry, particularly within the medical device, bio-pharmaceutical, or biotechnology sectors, with a strong preference for experience at the 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.
• 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).
• Experience with remediation efforts and FMEA process implementation with medical devices is a plus.
• Ability to analyze data from client's proprietary sources to calculate risk probabilities and levels effectively.
• Strong communication skills to relay department and area issues, ensuring clarity and cooperation across client's global functional teams.
• Technical experience with Pyxis or automated dispensing cabinets (preferred).
• Bachelor of Science degree in engineering (Mechanical, Electrical, Materials, Biomedical, or related discipline), with a master's degree preferred.
• Quality certifications relevant to client, such as ASQ Certified Quality Engineering, Certified Auditor, and Six Sigma credentials preferred.

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