What you need to know
We require applicants for the opportunity to become Regional Quality Manager for one of our key clients. This is an excellent opportunity for someone who has extensive experience working in a Quality function within the medical device industry and who has experience of managing leadership teams and/or senior personnel.
This job is an 18-month contract on full-time hours with an expectation of 40% travel to include the other company sites across the regions of Connacht and Leinster.
Your new job
As the Regional Quality Manager, you will report to the Director of Quality & Regulatory and in this role you will support the Quality Managers on each site to ensure all aspects of Quality Assurance are implemented and supported throughout all three company sites within your region. This will include supporting and reviewing your leadership team with INAB compliance requirements, audits, reporting and planning to ensure the documented Quality System is implemented and documented. You will have the authority to stop processing and/or testing with immediate effect in the event of an adverse Quality issue being detected
Key duties & responsibilities:
- The Country/Zone Quality Manager has specific authority and responsibility to:
- Initiate actions to prevent the occurrence of process non-conformity
- Identify and record and process quality problems.
- Initiate, recommend or provide solutions to quality problems through designated channels.
- Verify the implementation of solutions to quality problems.
- Control further processing, delivery or release of customer product pending completion of corrective action on non-conforming process.
- Responsible for ensuring process commissioning, validation and any subsequent revalidations deemed necessary as a result of facility engineering changes or customer product/requirements changes are documented, approved and implemented.
- Maintains liaison with national and other regulatory agencies as required to ensure Quality Standards remain in compliance.
- Provide leadership, technical and regulatory support to Site Quality Managers
- Ensure appropriate systems and processes are in place to ensure the timely release of client products post-processing, Document Control and Complaints
- Develop and maintain a LEAN culture across all sites whilst keeping Quality and Compliance at the forefront of operations
What are we looking for?
- Third-level Qualification in a Life Science (Microbiology or Chemistry)
- Will also consider third-level qualifications in Quality or Engineering
- 5+ years’ experience working in a Quality department
- 3+ years management experience of a Quality team
- Experience managing a leadership team would be highly advantageous
- Requires comprehensive knowledge and hands-on experience of quality standards and procedures; ideally, in the area of EO and irradiation sterilisation and validation.
- Working knowledge and experience of medical device, related GMP and an appreciation of the FDA compliance inspections.
Apply for this job now or get in touch with Gareth on 090 6490485.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
We Value Your Trust.