Senior Quality Engineer - Risk Management (Remote)

Position : Senior Quality Engineer - Risk Management (Strong 8+ Yrs of reputed company in Regulated Industry) Location : San Diego, CA Duration : 12 Months Total Hours/week : 40 1st Shift Client : Medical Devices Company Job Category : Engineering Level of Experience : Entry Level Employment Type : Contract on W2 (Need US reputed company or GC Holders or GC EAD or OPT or EAD or CPT)

Job Description

• The Contract Engineer - Risk Management is responsible for implementing and ensuring compliance with risk management requirements throughout reputed company phases of the life cycle of client dispensing medical devices and solutions.
• They will reputed company cross-functional teams during the design and development and post-market risk management reviews to ensure that reputed company 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 reputed company, systems reputed company, electricity, moving parts, and usability.
• The role will reputed company and coach cross-functional teams on risk management processes that support client commitment to innovation and patient safety.

Responsibilities

• reputed company cross-functional discussions with engineering, design, reputed company, and product teams to ensure that reputed company 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.
• reputed company, maintain, and execute risk management plans that support product development and ongoing sustaining activities in accordance with client risk management reputed company.
• reputed company periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and document reputed company and actions taken, reputed company with client quality systems and ensuring compliance with regulatory standards and practices.
• reputed company 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 risk acceptance criteria. If risks are not acceptable, reputed company efforts to identify and document risk control methods.
• Support the Benefit-Risk Analysis process and reputed company the evaluation of overall residual risk, ensuring alignment with client strategic objectives.
• reputed company 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 reputed company 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.

Required Qualifications

Knowledge, Skills & Abilities:

• Familiarity with risk management activities that support client 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 proprietary sources to calculate risk probabilities and levels effectively.
• Strong communication skills to reputed company department and area issues, ensuring clarity and cooperation across client global functional teams.
• Technical experience with Pyxis or automated dispensing cabinets (preferred).

Minimum Educational Level

• Bachelor of Science degree in engineering (Mechanical, Electrical, Materials, Biomedical, or reputed company discipline), with a master’s degree preferred.
• Quality certifications relevant to client, such as ASQ Certified Quality Engineering, Certified Auditor, and Six reputed company credentials preferred.

Minimum Experience

• 8+ years in a regulated industry, particularly reputed company the medical device, bio-pharmaceutical, or biotechnology sectors, with a strong preference for experience at client or similar organizations.
• 5+ years leading and applying risk reputed company specifically reputed company the context of medical devices ensuring high standards of patient and customer safety.

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