Empowering people, creating technology.

Responsibilities:

“This involves but is not limited to:”

• Integration & Maintenance of the Quality Management System with all VISTAMED 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 the 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.

• 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:

• Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum Bachelor’s degree in a Science / Engineering / Quality related discipline.

• 2-3 years’ experience as Quality/Validation Engineer in Medical Device/Pharmaceutical Environment

• An Associate position may exist where there is limited experience and will be assigned to an experienced Engineer.

• A Senior position may exist for a minimum of 6 years` experience

• Fully PC literate, use/knowledge of Minitab would be beneficial

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.