I am currently representing a leading international manufacturer within the medical device industry who produce THVs (heart valves).
If you are passionate about quality and precision, have a keen eye for detail and a strong background in scientific disciplines, we have an exciting opportunity for you. Due to company expansion my client is looking for experienced Quality Control Inspectors to join their team at their manufacturing site in Swillington, Leeds.
This is your chance to join a dedicated team and contribute to the production of life-saving medical devices. Work in a supportive environment where your skills and expertise will be valued.
Starting Salary: From £26,000
Hours: 7:00 AM - 2:30 PM, Monday to Friday
Key Responsibilities:
* Perform routine quality control tests and document results accurately.
* Ensure compliance with 21CFR820 and ISO 13485 requirements.
* Collaborate with manufacturing and engineering teams to address quality issues.
* Conduct routine testing on THV, to include functional, visual, and final inspection processes, along with supporting sterilization preparation.
* Perform Microbiological monitoring on ViVitro (Leeds) or BDC (Irvine) when required.
* Conduct Preventative Maintenance and calibration of the ViVitro (Leeds) or BDC (Irvine) equipment.
* Conduct audits on the in-process paperwork associated with the manufacturing process.
* Provide support to the Engineering staff by gathering data on clinical product to allow decisions to be made on functionality.
* Adhere to Quality System and record retention requirements.
* Contribute to continuous improvement efforts related to valve manufacture and inspection processes.
* Inspect final packaging labels and confirm they are applied correctly per the relevant standards and Work Instructions.
Qualifications:
* A Levels in a science-related discipline (biology, chemistry, etc.) are required.
* A bachelor’s degree in biology or chemistry is desirable.
* Familiarity with 21CFR820 and ISO 13485 requirements is essential.
* Experience in Quality within the medical devices or pharmaceutical industries is desirable.
Skills and Attributes:
* Strong attention to detail and analytical skills.
* Excellent communication and teamwork abilities.
* A proactive and problem-solving mindset.
* Ability to work independently and manage time effectively.
Note: this vacancy is being advertised by Ingenuity Employment Solutions ltd acting as an employment agency