Validation Engineer

Life Science Recruitment; Eu; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A leading medical device company is seeking a Validation Engineer to manage product introductions and ensure compliance with ISO standards. The ideal candidate will have a Bachelor's degree in a relevant field and at least 1 year of experience in quality assurance within the medical device industry. Competitive salary and benefits offered, including hybrid working options.

Prestations

Competitive salary

Bonus

Pension

Healthcare

Hybrid working

Qualifications

• Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device.
• 1+ years’ experience in a Quality role in a Medical Device/Pharmaceutical Environment.

Responsabilités

• Ensure product introductions & change controls are managed according to ISO 13485.
• Participate in new product introductions programmes.
• Complete Validation Programme – Risk Analysis, VMP, IQ’s, OQ’s, PQ’s.

Connaissances

ISO 13485 compliance

Validation techniques

Risk analysis

Attention to detail

Formation

Bachelor’s degree in Engineering / Science / Quality

Description du poste

Role: Validation Engineer
Location: Carrick on Shannon, Leitrim
Benefits: Competitive salary, Bonus, pension, healthcare and hybrid working

Company:
Work with the largest employer in Leitrim, specializing in making catheters all in-house. Work in a company with cleanrooms dedicated to customers, very specialized. Generally, have about 100 promotions per year – projects involved, individual plans, goal setting, leadership training.

Responsibilities

• Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485.
• Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845. Generation of Product Technical Files & associated studies
• Completion of Validation Programme – Risk Analysis, VMP, IQ’s, OQ’s, PQ’s as required according to procedure QAP 030 and other related procedures
• Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
• Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
• Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc).
• Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.

Qualifications

• Required: Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum Bachelor’s degree in a Science / Engineering / Quality related discipline.
• 1+ years’ experience in a Quality role in Medical Device/Pharmaceutical Environment
• An Associate position may exist where there is limited experience and will be assigned to an experienced Engineer.

We are an equal opportunities employer and welcome applications from all qualified candidates.