Quality Engineer (Temp)

Freudenberg Medical; Connacht; On-site; EUR 40,000 - 60,000; Part time

Benefits offered by this job

Corporate Events

Health Management

Health Insurance

Flexible Work Models

Welcome to career changers

Job summary

Freudenberg Medical Ireland Ltd. is seeking a Quality Engineer (Temp) to join our on‑site team in Carrick-on-Shannon, Co. Leitrim.

You will implement and maintain the QMS, support product introductions and change controls, and assist with CAPA and investigations to ensure compliant, high‑quality medical devices. The role requires 2–3 years in Quality/Validation within the medical device/pharma sector, a Bachelor’s degree in a related field, and solid PC/Minitab skills; ISO 13485/FDA knowledge is

Qualifications

• Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical.
• 2-3 years’ experience as Quality/Validation Engineer in Medical Device/Pharmaceutical Environment
• An Associate position may exist with limited experience; a Senior position may exist with 6+ years
• Fully PC literate; knowledge of Minitab beneficial
• Desirable: ISO 13485 and FDA 21 CFR Part 820 QMSR knowledge

Responsibilities

• Integrate and maintain the Quality Management System per ISO 13485 and MDR/QMSR requirements.
• Support departments to ensure products meet customer requirements.
• Review and release batch paperwork for product release.
• Participate in new product introductions and changes per ISO 13485 & FDA QMSR.
• Assist in CAPA, deviation handling and routine failure investigations.
• Coordinate calibration, validation and environmental/housekeeping programs.
• Support internal quality audits and corrective action programmes.

Skills

Quality Assurance

Validation Engineering

Documentation

Process Improvement

Minitab

Education

Bachelor's degree in Science/Engineering/Quality

Tools

Minitab

Job description

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.

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

Some of your Benefits

• Corporate Events: We celebrate success as a team, because only together can we achieve our goals.
• Health Management: We support you to stay and become healthy and fit.
• Health Insurance: Rely on comprehensive services whenever you need it.
• Flexible Work Models: We allow for flexible work models to ensure both professional and personal success.
• Welcome to career changers: We look forward to your application, even if you do not have specific prior experience. All you need is the willingness to grow and develop

Carrick-on-Shannon, Co. Leitrim

On-Site

Freudenberg Medical Ireland Ltd.

You support our team as

Quality Engineer (Temp)

Responsibilities

• “This involves but is not limited to:”
• Integration & Maintenance of the Quality Management System with all FM COS processes in accordance with the requirements of ISO 13485, FDA 21 CFR 820 Part QMSR, MDD 93/42/EEC & MDR 2017/745.
• 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, FDA 21 CFR 820 Part QMSR, 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 and FDA 21 CFR Part 820 QMSR. 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 troubleshooting
• Maintenance of plant Trending & Continuous process improvement programmes
• Participation in the Plant Corrective Action Programme & Internal Quality Audit Programme
• Co-ordination & maintenance of the Calibration Programme & Validation Programme
• Maintenance of the Plant Environmental & Cleaning/ Housekeeping Programme, including sub-contractor maintenance
• Maintenance of the Plant Laundry & Rodent Control Sub-Contractors to

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
• Desirable:
• Knowledge and understanding of ISO 13485 and FDA 21 CFR Part 820 QMSR requirements an advantage

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.