Quality Engineer (Temp Role)

at  Freudenberg Medical

Working at Freudenberg: “We will wow your world!” This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.
At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world. We are a global provider for medical device design and manufacturing with more than 2,500 employees. Innovation is at the core of our company, and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies. Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career. Come join us and together we can make a difference in the future of healthcare.

EDUCATION REIMBURSEMENT

Education Reimbursement: Receive financial aid to help propel your career to the next level.
Carrick-on-Shannon (Co. Leitrim)
On-Site
VistaMed Ltd.
You support our team as

QUALIFICATIONS

• The minimum criteria for the job candidate are specified.
• 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.
• 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.

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