Medical Device Quality Assurance Specialist

5 days ago

Islamabad, Islamabad, Pakistan Biointellisense Full time

About BioIntelliSense

BioIntelliSense is a leading provider of continuous health monitoring and clinical intelligence solutions. Our innovative technologies aim to transform care delivery from in-hospital to home, empowering clinicians with high-resolution vital sign trending and data-driven insights for better patient outcomes.

We are seeking a highly skilled Quality Engineer, Design Assurance to join our team and contribute to the development and implementation of design control processes that ensure the quality and safety of our medical devices.

This role will involve working closely with cross-functional teams to support new product introduction (NPI) and existing product sustaining processes. The successful candidate will have hands-on experience with medical device software (SaDM) and IEC 62305, as well as strong written and verbal communication skills.

Key Responsibilities:

  • Conduct product design control activities for NPI and sustaining D&D efforts.
  • Establish, maintain, and optimize D&D related processes, forms, templates, and tools.
  • Serve as Subject Matter Expert in BioIntelliSense design control and risk management SOPs and ensure they meet state-of-the-art regulatory requirements per FDA 21 CFR part 820, ISO 13485:2016, and European EU MDR.
  • Provide continuous guidance to other teams and functions to promote compliant and best practice D&D processes; conduct in-person or remote training on relevant subjects, as needed.
  • Take ownership of the quality and consistency of products' Design History Files (DHF) and, working with Project Management (PM), ensure the proper documentation is being generated and released to support the product development process through the company defined stage gates.
  • Provide Quality content review of D&D related deliverables.
  • Provide Risk Management oversight per ISO 14971 to establish a product life cycle review process that monitors and reduces product risk from early development through product release to the post-market monitoring stage.
  • Responsible for review and approval of project traceability matrices, assuring product requirements can be traced through design input to outputs and finally to verification and/or validation testing. Ensure adequate and timely review and update traceability process to include risk management mitigations.
  • Ensure proper product and component critical to quality characteristics are being defined.
  • Assist Regulatory FDA 510(k) submissions and other regulatory submissions.
  • Working with System Engineering, maintain technical standards and ensure the team is working on the state-of-the-art version of the standards. When needed, interact with third-party test houses that conduct compliance testing.

What You'll Bring:

  • Bachelor's or higher degree in engineering, technology, or science.
  • 5+ years of experience in design control or design assurance functions in a medical device company.
  • Hands-on experience with medical device software (SaDM) and IEC 62305.
  • Hands-on experience with risk management activities per ISO 14971.
  • Strong written and verbal communication skills.
  • Strong interpersonal skills; Ability to interact with all levels and disciplines of employees.
  • Organized and able to prioritize duties and responsibilities.

Why Work at BioIntelliSense?

BioIntelliSense is a fast-growing company that values innovation, collaboration, and customer satisfaction. We offer a dynamic work environment, opportunities for professional growth, and a comprehensive benefits package.

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