Senior Quality Assurance Specialist
Job Description
We are seeking a skilled Senior Quality Assurance Specialist to support our client, a medical device startup company. The successful candidate will work closely with the Senior Quality Manager to ensure the quality management system is maintained and up-to-date.
Key Responsibilities:
* Provide quality support during in-house manufacture and lot release.
* Develop and implement quality plans, programs, and procedures for commercialization.
* Ensure all work is carried out in compliance with quality, regulatory, and company policies and systems.
* Review, analyze, and report on quality discrepancies related to product design and manufacture.
* Liaise with OEM contractors/vendors during the manufacture of components.
* Support during regulatory agency audits, including FDA and Notified Body audits.
Required Skills and Qualifications
To be successful in this role, you will need:
* A bachelor's degree in a relevant engineering or science field.
* At least 5 years' experience in the medical device industry or equivalent higher-level postgraduate study (masters or PhD).
* Strong project planning, communication, and writing skills.
* A sound understanding of engineering fundamentals.
* Knowledge of medical device quality and regulatory systems, including ISO13485 and FDA CFR 820.
* Cleanroom and sterilization experience is preferred.
* Process validation experience is preferred.
Benefits
This is an excellent opportunity to join a dynamic team and contribute to the success of our client's medical device startup company. As a Senior Quality Assurance Specialist, you will have the chance to work on challenging projects, develop your skills, and advance your career.
Others
If you are interested in this role, please contact James Cassidy or call in confidence at 086 0204322 for further information.