**Job Title:** Quality Assurance Associate
About the Role:
We are seeking a skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for assisting in the maintenance of our Quality Management System (QMS), managing internal processes and external vendors to ensure product quality.
Your Key Responsibilities Will Include:
* Maintaining the effectiveness of our QMS and making continuous improvements to it.
* Managing day-to-day QA activities, including frequent interface with contract manufacturers, QA consultants and testing contractors as well as handling multiple projects related to product and compliance enhancements.
* Assisting in notified body audits and internal audits.
* Maintaining and coordinating quality system schedules, including: Supplier and internal audits; management review and documentation updates.
* Supporting the wider team to ensure product manufacture and testing meets the requirements.
* Building and maintaining strong relationships with suppliers, monitoring their performance, and conducting audits to ensure compliance with quality standards.
* Investigating, analysing, and resolving any product quality problems, including root cause analysis and implementing corrective and preventive actions.
* Ensuring that incoming materials meet the required specifications and working with the engineering team to address any quality concerns.
The Ideal Candidate Will Have:
* A Bachelor's degree in engineering or science.
* Quality certification in ISO 13485 is a must.
* A minimum of 4 years of experience in a medical device QA position(s) role within a medical device organisation.
* Thorough understanding and knowledge of ISO 13485 and ISO 14971, EU MDR and 21 CFR Part 820.
* Desirable to have lead auditor certification and/or Regulatory certifications.
* Proven track record with the ability to successfully manage projects to deadlines.
* Good Documentation Practice experience.
* Report & Technical Writing experience.
* Project Management experience.
* Strong ability to manage critical projects as part of an interdisciplinary team.
* Excellent problem solving and communication skills.
Benefits:
This is an exciting opportunity to work in a dynamic environment with a talented team of professionals. We offer a competitive salary package, 10% bonus, hybrid working, healthcare and pension benefits.