Back to Job SearchROLE OVERVIEW
We are currently looking for a QA Specialist – Design Controls Remediation to join a leading medical device company based in the US. This is an exciting opportunity for a Quality Assurance professional to contribute to a critical remediation program supporting regulatory compliance and quality standards. The role offers a remote working environment, allowing you to work flexibly while ensuring high-quality documentation and adherence to industry regulations.
As part of our client’s team, you will play a key role in reviewing and improving design control documentation across the product lifecycle, ensuring compliance with regulatory frameworks and internal quality processes. This position is ideal for someone with proven experience in medical device QA and a keen eye for detail in documentation reviews and process improvements.
KEY DUTIES AND RESPONSIBILITIE
Your duties as the QA Specialist – Design Controls Remediation will be varied however the key duties and responsibilities are as follows:
- Conduct independent QA reviews of design control documentation, including User Needs, Design Inputs and Outputs, Verification, Validation, and Transfer activities.
- Assess documentation for completeness, consistency, and traceability, ensuring alignment with applicable regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and internal procedures.
- Identify and document gaps, inconsistencies, and potential risks within the Design History File, providing clear feedback and actionable recommendations.
- Collaborate with remediation and engineering teams to address issues and improve documentation compliance.
- As the QA Specialist, you will ensure that all design control files meet regulatory standards and support ongoing product development.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the QA Specialist – Design Controls Remediation we are looking to identify the following on your profile and past history:
- A Degree or higher level in a related field (e.g., Biomedical Engineering / Quality Assurance / Life Sciences).
- Proven industry experience in Quality Assurance within regulated industries, with a strong preference for medical devices.
- A working knowledge and practical experience with regulatory standards and frameworks, including FDA 21 CFR Part 820 and ISO 13485.
WHAT’S IN IT FOR YOU?
Joining our client provides a unique opportunity to work on impactful projects within the global medical device industry, supporting high standards of quality and compliance. You will be part of a forward-thinking team that values innovation and continuous improvement, all while enjoying flexible remote working arrangements and career development opportunities.
Key Words: QA Specialist / Design Controls / Remediation / DHF / Quality Assurance / Medical Devices / Regulatory Compliance / FDA 21 CFR Part 820 / ISO 13485 / Documentation Review / Remote Work.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
