Senior Quality Engineer at Life Science Recruitment

Job Description:

Latest job information from Life Science Recruitment for the position of Senior Quality Engineer. If the Senior Quality Engineer vacancy in Connacht matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.

Please note that applying for a job may not always be easy, as new candidates must meet certain qualifications and requirements set by the company. We hope the career opportunity at Life Science Recruitment for the position of Senior Quality Engineer below matches your qualifications.

Overview

Role: Senior Quality EngineerLocation: Carrick on Shannon, LeitrimBenefits: Competitive salary, Bonus, pension and healthcare

Company:Work with the Largest employer in Leitrim specializing in making Catheters inhouse. Cleanrooms dedicated to customers, highly specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training.

• Integration & Maintenance of the Quality Management System with all Freudenberg Medical processes in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
• Deputising for the Management Representative in their absence.
• Provision of support to all departments to ensure that products manufactured meet customer requirements.
• Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
• Review and Release of batch paperwork for Product release.
• Participation in new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13485. Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.
• Maintenance of the Customer Complaint investigation process, MDD 93/42/EEC & MDR 2017/745 vigilance requirements assisting in product recalls & corrective/ preventive action programme.
• Participation in routine Failure Investigation & process trouble-shooting.
• Maintenance of plant Trending & Continuous process improvement programmes.
• Participation in the Plant Corrective Action Programme.
• Participation in the Internal Quality Audit Programme.
• Co-ordination & maintenance of the Calibration Programme.
• Co-ordination & maintenance of the Validation Programme.
• Maintenance of the Plant Environmental & Cleaning/ Housekeeping Programme, including sub-contractor maintenance.
• Maintenance of the Plant Laundry & Rodent Control Sub-Contractors to required standards.
• Vendor Assessment liaison & Maintenance.
• Ensuring that quality system & product requirements are included in the plant Training Programmes designated trainer.
• 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.

• 2-3 years’ experience as Quality/Validation Engineer in Medical Device/Pharmaceutical Environment
• Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum Bachelor’s degree in a Science / Engineering / Quality related discipline
• An Associate position may exist where there is limited experience and will be assigned to an experienced Engineer.

Does this sound like your next career move? For more info forward your application or contact me on R #J-18808-Ljbffr

Job Info:

• Company: Life Science Recruitment
• Position: Senior Quality Engineer
• Work Location: Connacht
• Country: IE

How to Submit an Application:

After reading and understanding the criteria and minimum qualification requirements explained in the job information Senior Quality Engineer at the office Connacht above, immediately complete the job application files such as a job application letter, CV, photocopy of diploma, transcript, and other supplements as explained above. Submit via the Next Page link below.