Quality Engineer

Job DescriptionCompany description: At Vital Healthcare we provide the medical devices, medicines and diagnostic products that help healthcare professionals and patients across the Island of Ireland and the UK manage illness and restore health. But what we deliver is more than simply the mechanics of treatment. We seek to be the best service provider of Medical Devices, Medicines and Services to the healthcare sector.

Our brands in Ireland include Fannin & Medisource. With the heritage of care giving dating back to 1829 we have the track record to support our claims. We deliver confidence in our ability, we have the financial strength to sustain and develop our business which is underpinned by our dedicated workforce.

Fannin is continually expanding its product portfolio in both the medical and pharma sectors both organically and through acquisition. We have an active partnering strategy and are always seeking partnership opportunities in the fields of pharmaceuticals, medical devices and diagnostic products. Whether youre a manufacturer seeking a distribution partner for the UK or the Irish market, a healthcare professional looking to commercialise an innovative concept, or a start-up in the med-tech sector, Fannin has expertise to deliver your products.

In recent years, we have made a number of acquisitions in the pharma and medical devices sectors which provide us with the perfect platform for growth in our existing markets and new growth areas. All of these relationships mean that we can bring you more more products, more know-how and more ways to care for life. For information about job opportunities at Fannin and across the wider Vital Healthcare business, please our careers site.

Job description: The Opportunity Fannin LIP Galway is currently seeking a Quality Engineer to join our team at the Galway manufacturing facility. The role provides quality support and oversees validations, monitoring, and calibration activities across the site ensuring compliance with regulatory requirements and company quality standards. Principal Duties and Responsibilities: Provide quality support to the various departments across the site to ensure effective maintenance and implementation of the Quality management Systems.

Ensure compliance to GMP, EU IVDR, and applicable regulatory requirements. Support regulatory inspections, customer audits, and internal quality audits. Develop, maintain, and ensure implementation of in-house documents e.g.

Standard Operating Procedures, Validation Protocols, Risk Assessments, technical files, etc. Support issues management (Complaints, and Vigilance activities) Oversee and manage equipment qualification, validation and calibration activities for the site to ensure compliance with GMP, quality and regulatory requirements. Oversee the operations of onsite monitoring systems Perform quality assurance activities to ensure that raw material and finished product meet established quality, safety and performance standards.

Support in the management of site level quality risk management and associated documentation. Drive continuous improvements initiatives across site relating to manufacturing, maintenance and quality systems. Lead quality related projects as assigned by Site Quality manager ensuring that they are delivered on time and within budget.

Profile description: Experience & Profile: Relevant Third Level qualification in science, quality or a related discipline (microbiology or validation qualification is an advantage) Experience in a regulated manufacturing environment, EU IVDR, EU MDR, GMP/GDP, and quality management systems ((ISO 17025/ISO 9001/ISO 13485). Experience with medical device risk management in accordance with ISO 14971 is preferable Experience in supporting validation activities e.g. equipment and/or testing qualification (IQ/OQ/PQ), change management and non-conformance investigations. Demonstrated project Management experience Auditor certified is an advantage Other Information: Strong analytical, communication and problem-solving skills are required for the role.

Ability to work collaboratively across quality, manufacturing operations, and supply chain teams. Ability to independently priorities workload and manage competing demands in a fast-paced environment. Flexibility to travel to support supplier audits as required.

Skills: Attention to detail Time Management Interpersonal Skills Benefits: Bonus Life Assurance Paid Holidays Pension TPBN1_IJ