Medical Device Quality Assurance Specialist

1 month ago


Pleasanton, California, United States BioSpace, Inc. Full time
Job Details

About Us

At BioSpace, Inc., we are dedicated to delivering innovative solutions that transform lives. Our mission is to push the boundaries of what is possible in the medical device industry, and we are seeking a talented individual to join our team as a Medical Device Quality Assurance Intern.

Job Description

The Medical Device Quality Assurance Intern will play a critical role in ensuring the quality and safety of our medical devices. This will involve collaborating with cross-functional teams to develop and implement quality assurance processes, conducting design verification and validation activities, and analyzing product requirements and specifications. The ideal candidate will have a strong understanding of quality systems and regulatory requirements, as well as excellent communication and problem-solving skills.

Key Responsibilities:

  • Collaborate with design teams to provide technical support and facilitate the successful execution of the design control process for complex electromechanical medical devices.
  • Create quality engineering deliverables required within the product development process.
  • Support design verification and validation activities, including review of verification and validation protocols and reports.
  • Assist in the analysis of product requirements and specifications, and participate in product design reviews and team meetings.
  • Provide subject expertise and input in areas such as biocompatibility strategy, shelf-life studies, and cleaning validation.
  • Ensure that technical information is accurate and in compliance with quality and regulatory requirements.
  • Review design changes post-design transfer.
  • Work on process improvements globally or at the site level.
  • Prepare information for communication and knowledge sharing using various methods.
  • Learn about R&D QA quality systems in a regulated environment.


Qualifications:

  • Currently enrolled in a university, pursuing a Bachelor's degree in bioengineering, biomedical engineering, mechanical engineering, or a related scientific/engineering field.
  • Must be enrolled in a university for at least one semester following the internship.
  • Expected graduation date between December 2025 and June 2026.


Benefits and Amenities:

  • Competitive pay.
  • Relocation support for eligible students.
  • Select wellness benefits and paid holiday/sick time.


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