Contact: Bimi Felix
Complaints and Sustaining Engineer
Our client, a medical device company in Galway are currently looking to recruit Complaints and Sustaining Engineer for their site.
The Engineer will work in a cross functional Sustaining, Research & Development, Quality and Operations team in sustaining the portfolio of Legally Manufactured products. This key position within the Sustaining Engineering group will enable the successful candidate to demonstrate their broad range of engineering skills in a fast paced dynamic environment. In working on these diverse products and projects the successful candidate will have the opportunity to work with other cross functional team members. Based out of our Parkmore facility the successful candidate will report to the Complaints & Sustaining Manager.
- Support the maintenance of product files and other relevant documentation to comply with quality standards.
- Review and analyse returned complaints in Complaints Returns Lab also providing investigation reports and root cause analysis.
- Coordinate and lead sustaining engineering projects on legally manufactured products.
- Provide customers with accurate complaint analysis trending and reports.
- Complete/assist in the assessment of design changes and product changes for Legally manufactured products (DCAF & PCRAF)
- Preparation of ad-hoc reports of product complaint and adverse event trends as required.
- Identify product improvement opportunities through product complaint, adverse event trend and customer feedback.
- Complete the execution of shelf life testing by maintaining records of testing dates and requirements.
- Complete/co-ordinate additional testing to meet new regulatory requirements/ customer requirements.
- Participate in internal and external quality system audits conducted by FDA and notified body representatives.
- Work within Sustaining Group ensuring regulatory requirements and changes are met.
- Apply new and existing technologies to provide the optimum delivery system design.
- Provide support to maintain compliance with all FDA, and other U.S., and international regulatory requirements as applicable, specifically in the Europe region.
- BS Degree in technical or scientific field or equivalent work experience
- Minimum 3-5 years' experience in medical device/ Pharma industry.
- Experience with engineering tools such as AutoCAD, Minitab.
- Demonstrate product design and development experience, including experience of sustaining activities.
- Experience of compiling FMEA’s and conducting verifications and validations for medical devices products and processes.
- Excellent Technical writing experience in a medical device environment.
- Ability to interface with all levels of management.
- Self-starter who works well under minimal supervision
- Attention to detail - reliable and consistent in review of records
- Excellent communication skills (verbal and written). Communicates in a professional and courteous manner.
For further information on this role Complaints and Sustaining Engineer in Galway please contact Bimi Felix on 091730022 / email@example.com
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