Job Summary

Sr. Quality Engineer

  • Location:
    San Diego, California
  • Job reference:
    US_EN_3_105432_322306
  • Category:
    Quality
  • Contract Type:
    Contract/Temporary

Summary:
Risk Management 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 product development projects and platforms.
Provide guidance to team on risk management, regulatory and quality engineering policies, principles and best practices.
Facilitate development and completion of risk management deliverables between systems by collaboratively working with quality, R&D, engineering, marketing and clinical.
Develop and maintain Risk Management Files according to ISO 14971 and ensure Risk Management Files are updated per defined schedules and frequencies.


Sr. Quality Engineer- Risk Management
San Diego, CA


Required Skills and Knowledge:

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.
Teamwork oriented and ability to lead and influence with proven problem-solving skills.
Consistent application of technical principles, theories, concepts and quality sciences / tools and demonstrates knowledge of FDA/ISO requirements.
Excellent communication and writing skills, this role will require writing quality reports and presentations for executive management and auditors.


Qualifications:

Bachelor's degree in technical field and 7-10 years of experience is required; or equivalent combination of education and experience.
Direct experience with medical devices in a regulatory environment
Infusion pump hardware/software/disposables experience is preferred
Interoperability experience with hospital connectivity information systems is preferred




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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal employment opportunity information:
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