Staff Quality Engineer- Risk Management- Post Market Surveillance

BD (Becton, Dickinson And Company) San Diego , CA 92140

Posted 4 days ago

Job Description: Summary

Staff Quality Risk Management Engineer who is responsible for leading Post Market Surveillance risk management activities through the application of Quality engineering and risk management skills for medical devices. This person will handle Post Market Risk Management activities for products in the field and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and business unit policies, while meeting all design control and other regulatory requirements.

Job Description

Summary

The Staff Quality Engineer is accountable for supporting risk management activities for new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and business unit policies, while meeting all design control and other regulatory requirements.

Primary Responsibilities:

  • Provide Risk Management technical expertise through the product life cycle for new and sustaining product development projects and platforms.

  • Demonstrates knowledge of risk management, regulatory and quality engineering policies, principles and best practices

  • Develop and maintain Risk Management Files according to ISO 14971 and ensure Risk Management Files are updated per defined schedules and frequencies.

  • Collaborative work with quality, R&D, engineering, marketing and clinical.

  • Facilitate development and completion of risk assessments for field issues/complaints in the field.

  • Manage Risk Management activities and mentors resources for design and development projects.

  • Proven problem solving skills

  • Consistent application of technical principles, theories, concepts and quality sciences / tools.

  • Demonstrates knowledge of FDA/ISO requirements

  • Drive measureable improvements to BD processes and procedures.

  • Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross function teams;

  • Prepares/Revises policies/procedures based on industry standards for Quality Management Systems and Design Controls.

  • Consistent application of technical principles, theories, concepts and quality sciences / tools.

Minimum Qualifications

  • Bachelor's Degree in a technical field and 7-10 years of experience is required; or equivalent combination of education and experience.

  • Teamwork oriented and ability to lead and influence

  • Direct experience with medical devices in a regulatory environment

  • Excellent communication and writing skills, this role will require writing quality reports and presentations for executive management and auditors

  • Strong knowledge of Risk Management discipline and must be able to apply quality principles (GMPs, 21 CFR, EN ISO 14971:2012, IEC 60601-1, ISO 13485, EN 62304, IEC 62366, FDA Guidance - Cyber Security, interoperability, assurance cases etc.) to the R&D environment.

  • Proven track record of initiating and driving continuous improvements

  • Teamwork oriented and ability to lead and influence

  • Infusion pump hardware/software/disposables experience is preferred

  • Leadership or supervisory experience is preferred

#LI-OPS

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift


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Staff Quality Engineer- Risk Management- Post Market Surveillance

BD (Becton, Dickinson And Company)