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Staff Quality Engineer- Risk Management

Apply Now Job ID R-21474 Date posted 10/05/2017

Job Description Summary

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.

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

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status

#LI-OPS 

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com