Back to Job SearchROLE OVERVIEW
We are currently looking for a Clinical QA/PMS Specialist to join a leading healthcare company on a 12-month remote contract. This is an exciting opportunity for a professional with a strong background in quality assurance and post-market surveillance to contribute to a company dedicated to advancing healthcare standards.
As a pivotal member of the team, you will be responsible for overseeing quality compliance processes, managing surveillance activities, and supporting continuous improvement initiatives within the organisation.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Clinical QA/PMS Specialist will be varied however the key duties and responsibilities are as follows:
- Manage Post-Market Surveillance (PMS) Review Board meetings, including planning cadence, preparing materials, and presenting results.
- Facilitate moderate to complex complaint investigations, providing timely and insightful responses.
- Perform data queries, trend analyses, and statistical evaluations to identify emerging product issues.
- Ensure application of corrective actions for unacceptable trends to reduce defects and meet quality objectives.
- As the Clinical QA/PMS Specialist you will contribute to maintaining compliance with relevant regulations and standards.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Clinical QA/PMS Specialist we are looking to identify the following on your profile and past history:
- A Degree or higher level in Engineering or a related field.
- Proven industry experience in quality systems, complaint management, or post-market surveillance.
- A working knowledge and practical experience with FDA regulations, ISO 13485, ISO 14971, EU MDR, and related ISO/AAMI standards.
WHAT’S IN IT FOR YOU?
Joining our client offers the chance to be part of a forward-thinking healthcare organisation, with opportunities to develop your expertise in a supportive and innovative environment. This role provides remote working flexibility and the experience of working on impactful projects within a dynamic team.
Key Words: Clinical QA / Post-Market Surveillance / PMS Specialist / Quality Systems / Complaint Management / FDA Regulations / ISO 13485 / ISO 14971 / EU MDR / Data Analysis
"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."
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.
